Diabetes

Among adults at high risk of type 2 diabetes – the leading cause of kidney disease – those who received vitamin D supplements as opposed to placebo for close to 3 years did not have significant differences in kidney function, in a secondary analysis of the Vitamin D and Type 2 Diabetes (D2d) study.

However, most of these adults with prediabetes plus obesity or overweight also had sufficient serum levels of 25-hydroxyvitamin D (25[OH]D) and a low risk for adverse kidney outcomes at study entry.

“The benefits of vitamin D might be greater in people with low blood vitamin D levels and/or reduced kidney function,” lead author Sun H. Kim, MD, Stanford (Calif.) University, speculated in a statement from the American Society of Nephrology.

The study was published online August 6 in the Clinical Journal of the American Society of Nephrology.

“The D2d study is unique because we recruited individuals with high-risk prediabetes, having two out of three abnormal glucose values, and we recruited more than 2,000 participants, representing the largest vitamin D diabetes prevention trial to date,” Dr. Kim pointed out.

Although the study did not show a benefit of vitamin D supplements on kidney function outcomes, 43% of participants were already taking up to 1,000 IU of vitamin D daily when they entered the study, she noted.

A subgroup analysis of individuals who were not taking vitamin D at study entry found that vitamin D supplements were associated with lowered proteinuria, “which means that it could have a beneficial effect on kidney health,” said Dr. Kim, cautioning that “additional studies are needed to look into this further.”
 

Effect of vitamin D on three kidney function outcomes

Although low levels of serum 25(OH)D are associated with kidney disease, few trials have evaluated how vitamin D supplements might affect kidney function, Dr. Kim and colleagues write.

The D2d trial, they note, found that vitamin D supplements did not lower the risk of incident diabetes in people with prediabetes recruited from medical centers across the United States, as previously reported in 2019.

However, since then, meta-analyses that included the D2d trial have reported a significant 11%-12% reduction in diabetes risk in people with prediabetes who took vitamin D supplements.

The current secondary analysis of D2d aimed to investigate whether vitamin D supplements affect kidney function in people with prediabetes.

A total of 2,166 participants in D2d with complete kidney function data were included in the analysis.

The three study outcomes were change in estimated glomerular filtration rate (eGFR) from baseline, change in urine albumin-to-creatinine ratio (UACR) from baseline, and worsening Kidney Disease: Improving Global Outcomes (KDIGO) risk score (which takes eGFR and UACR into account).

At baseline, patients were a mean age of 60, had a mean body mass index (BMI) of 32 kg/m², and 44% were women.

Most (79%) had hypertension, 52% were receiving antihypertensives, and 33% were receiving an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB).

Participants had a mean serum 25(OH) level of 28 ng/mL.

They had a mean eGFR of 87 mL/min/1.73 m² and a mean UACR of 11 mg/g. Only 10% had a moderate, high, or very high KDIGO risk score.

Participants were randomized to receive a daily gel pill containing 4,000 IU vitamin D3 (cholecalciferol) or placebo.

Medication adherence was high (83%) in both groups during a median follow-up of 2.9 years.

There was no significant between-group difference in the following kidney function outcomes:

• 28 patients in the vitamin D group and 30 patients in the placebo group had a worsening KDIGO risk score.
• The mean difference in eGFR from baseline was -1.0 mL/min/1.73 m² in the vitamin D group and -0.1 mL/min/1.73 m² in the placebo group.
• The mean difference in UACR from baseline was 2.7 mg/g in the vitamin D group and 2.0 mg/g in the placebo group.  

The authors have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Among adults at high risk of type 2 diabetes – the leading cause of kidney disease – those who received vitamin D supplements as opposed to placebo for close to 3 years did not have significant differences in kidney function, in a secondary analysis of the Vitamin D and Type 2 Diabetes (D2d) study.

However, most of these adults with prediabetes plus obesity or overweight also had sufficient serum levels of 25-hydroxyvitamin D (25[OH]D) and a low risk for adverse kidney outcomes at study entry.

“The benefits of vitamin D might be greater in people with low blood vitamin D levels and/or reduced kidney function,” lead author Sun H. Kim, MD, Stanford (Calif.) University, speculated in a statement from the American Society of Nephrology.

The study was published online August 6 in the Clinical Journal of the American Society of Nephrology.

“The D2d study is unique because we recruited individuals with high-risk prediabetes, having two out of three abnormal glucose values, and we recruited more than 2,000 participants, representing the largest vitamin D diabetes prevention trial to date,” Dr. Kim pointed out.

Although the study did not show a benefit of vitamin D supplements on kidney function outcomes, 43% of participants were already taking up to 1,000 IU of vitamin D daily when they entered the study, she noted.

A subgroup analysis of individuals who were not taking vitamin D at study entry found that vitamin D supplements were associated with lowered proteinuria, “which means that it could have a beneficial effect on kidney health,” said Dr. Kim, cautioning that “additional studies are needed to look into this further.”
 

Effect of vitamin D on three kidney function outcomes

Although low levels of serum 25(OH)D are associated with kidney disease, few trials have evaluated how vitamin D supplements might affect kidney function, Dr. Kim and colleagues write.

The D2d trial, they note, found that vitamin D supplements did not lower the risk of incident diabetes in people with prediabetes recruited from medical centers across the United States, as previously reported in 2019.

However, since then, meta-analyses that included the D2d trial have reported a significant 11%-12% reduction in diabetes risk in people with prediabetes who took vitamin D supplements.

The current secondary analysis of D2d aimed to investigate whether vitamin D supplements affect kidney function in people with prediabetes.

A total of 2,166 participants in D2d with complete kidney function data were included in the analysis.

The three study outcomes were change in estimated glomerular filtration rate (eGFR) from baseline, change in urine albumin-to-creatinine ratio (UACR) from baseline, and worsening Kidney Disease: Improving Global Outcomes (KDIGO) risk score (which takes eGFR and UACR into account).

At baseline, patients were a mean age of 60, had a mean body mass index (BMI) of 32 kg/m², and 44% were women.

Most (79%) had hypertension, 52% were receiving antihypertensives, and 33% were receiving an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB).

Participants had a mean serum 25(OH) level of 28 ng/mL.

They had a mean eGFR of 87 mL/min/1.73 m² and a mean UACR of 11 mg/g. Only 10% had a moderate, high, or very high KDIGO risk score.

Participants were randomized to receive a daily gel pill containing 4,000 IU vitamin D3 (cholecalciferol) or placebo.

Medication adherence was high (83%) in both groups during a median follow-up of 2.9 years.

There was no significant between-group difference in the following kidney function outcomes:

• 28 patients in the vitamin D group and 30 patients in the placebo group had a worsening KDIGO risk score.
• The mean difference in eGFR from baseline was -1.0 mL/min/1.73 m² in the vitamin D group and -0.1 mL/min/1.73 m² in the placebo group.
• The mean difference in UACR from baseline was 2.7 mg/g in the vitamin D group and 2.0 mg/g in the placebo group.  

The authors have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Among adults at high risk of type 2 diabetes – the leading cause of kidney disease – those who received vitamin D supplements as opposed to placebo for close to 3 years did not have significant differences in kidney function, in a secondary analysis of the Vitamin D and Type 2 Diabetes (D2d) study.

However, most of these adults with prediabetes plus obesity or overweight also had sufficient serum levels of 25-hydroxyvitamin D (25[OH]D) and a low risk for adverse kidney outcomes at study entry.

“The benefits of vitamin D might be greater in people with low blood vitamin D levels and/or reduced kidney function,” lead author Sun H. Kim, MD, Stanford (Calif.) University, speculated in a statement from the American Society of Nephrology.

The study was published online August 6 in the Clinical Journal of the American Society of Nephrology.

“The D2d study is unique because we recruited individuals with high-risk prediabetes, having two out of three abnormal glucose values, and we recruited more than 2,000 participants, representing the largest vitamin D diabetes prevention trial to date,” Dr. Kim pointed out.

Although the study did not show a benefit of vitamin D supplements on kidney function outcomes, 43% of participants were already taking up to 1,000 IU of vitamin D daily when they entered the study, she noted.

A subgroup analysis of individuals who were not taking vitamin D at study entry found that vitamin D supplements were associated with lowered proteinuria, “which means that it could have a beneficial effect on kidney health,” said Dr. Kim, cautioning that “additional studies are needed to look into this further.”
 

Effect of vitamin D on three kidney function outcomes

Although low levels of serum 25(OH)D are associated with kidney disease, few trials have evaluated how vitamin D supplements might affect kidney function, Dr. Kim and colleagues write.

The D2d trial, they note, found that vitamin D supplements did not lower the risk of incident diabetes in people with prediabetes recruited from medical centers across the United States, as previously reported in 2019.

However, since then, meta-analyses that included the D2d trial have reported a significant 11%-12% reduction in diabetes risk in people with prediabetes who took vitamin D supplements.

The current secondary analysis of D2d aimed to investigate whether vitamin D supplements affect kidney function in people with prediabetes.

A total of 2,166 participants in D2d with complete kidney function data were included in the analysis.

The three study outcomes were change in estimated glomerular filtration rate (eGFR) from baseline, change in urine albumin-to-creatinine ratio (UACR) from baseline, and worsening Kidney Disease: Improving Global Outcomes (KDIGO) risk score (which takes eGFR and UACR into account).

At baseline, patients were a mean age of 60, had a mean body mass index (BMI) of 32 kg/m², and 44% were women.

Most (79%) had hypertension, 52% were receiving antihypertensives, and 33% were receiving an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB).

Participants had a mean serum 25(OH) level of 28 ng/mL.

They had a mean eGFR of 87 mL/min/1.73 m² and a mean UACR of 11 mg/g. Only 10% had a moderate, high, or very high KDIGO risk score.

Participants were randomized to receive a daily gel pill containing 4,000 IU vitamin D3 (cholecalciferol) or placebo.

Medication adherence was high (83%) in both groups during a median follow-up of 2.9 years.

There was no significant between-group difference in the following kidney function outcomes:

• 28 patients in the vitamin D group and 30 patients in the placebo group had a worsening KDIGO risk score.
• The mean difference in eGFR from baseline was -1.0 mL/min/1.73 m² in the vitamin D group and -0.1 mL/min/1.73 m² in the placebo group.
• The mean difference in UACR from baseline was 2.7 mg/g in the vitamin D group and 2.0 mg/g in the placebo group.  

The authors have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has expanded the label for Eli Lilly’s ultra–rapid-acting insulin lispro-aabc injection 100 units/mL (Lyumjev) for use in insulin pumps.

Olivier Le Moal/Getty Images

Lyumjev (insulin lispro-aabc injection 100 and 200 units/mL) was initially approved in June 2020 to improve glycemic control in adults with type 1 or type 2 diabetes. That formulation is administered by injection from a pen or syringe. Now, the 100 units/mL formulation can also be delivered via continuous subcutaneous insulin infusion with an insulin pump.

Lyumjev will compete with Novo Nordisk’s fast-acting insulin aspart injection 100 units/mL (Fiasp). Fiasp had a head start: it was approved for use in adults in the United States in September 2017. It was approved for use in insulin pumps in October 2019 and for use in children with diabetes in January 2020.

The new approval for Lyumjev was based on data from a phase 3 trial, PRONTO-Pump-2. That trial, which included 432 participants with type 1 diabetes, confirmed the drug’s safety and efficacy when used in pumps.

The study met the primary endpoint of noninferiority in reduction of hemoglobin A1c from baseline to week 16, compared with insulin lispro (Humalog 100 units/mL). It was superior in both 1-hour and 2-hour postprandial glucose reduction when delivered 0-2 minutes before meals, according to a Lilly statement.

Patients who cannot afford the drug can go to www.insulinaffordability.com for assistance. Those with commercial insurance can also visit www.Lyumjev.com to access the Lyumjev Savings Card.

Lyumjev is available in several global markets, including Japan and the European Union, where it is also approved for use in insulin pumps.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has expanded the label for Eli Lilly’s ultra–rapid-acting insulin lispro-aabc injection 100 units/mL (Lyumjev) for use in insulin pumps.

Olivier Le Moal/Getty Images

Lyumjev (insulin lispro-aabc injection 100 and 200 units/mL) was initially approved in June 2020 to improve glycemic control in adults with type 1 or type 2 diabetes. That formulation is administered by injection from a pen or syringe. Now, the 100 units/mL formulation can also be delivered via continuous subcutaneous insulin infusion with an insulin pump.

Lyumjev will compete with Novo Nordisk’s fast-acting insulin aspart injection 100 units/mL (Fiasp). Fiasp had a head start: it was approved for use in adults in the United States in September 2017. It was approved for use in insulin pumps in October 2019 and for use in children with diabetes in January 2020.

The new approval for Lyumjev was based on data from a phase 3 trial, PRONTO-Pump-2. That trial, which included 432 participants with type 1 diabetes, confirmed the drug’s safety and efficacy when used in pumps.

The study met the primary endpoint of noninferiority in reduction of hemoglobin A1c from baseline to week 16, compared with insulin lispro (Humalog 100 units/mL). It was superior in both 1-hour and 2-hour postprandial glucose reduction when delivered 0-2 minutes before meals, according to a Lilly statement.

Patients who cannot afford the drug can go to www.insulinaffordability.com for assistance. Those with commercial insurance can also visit www.Lyumjev.com to access the Lyumjev Savings Card.

Lyumjev is available in several global markets, including Japan and the European Union, where it is also approved for use in insulin pumps.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has expanded the label for Eli Lilly’s ultra–rapid-acting insulin lispro-aabc injection 100 units/mL (Lyumjev) for use in insulin pumps.

Olivier Le Moal/Getty Images

Lyumjev (insulin lispro-aabc injection 100 and 200 units/mL) was initially approved in June 2020 to improve glycemic control in adults with type 1 or type 2 diabetes. That formulation is administered by injection from a pen or syringe. Now, the 100 units/mL formulation can also be delivered via continuous subcutaneous insulin infusion with an insulin pump.

Lyumjev will compete with Novo Nordisk’s fast-acting insulin aspart injection 100 units/mL (Fiasp). Fiasp had a head start: it was approved for use in adults in the United States in September 2017. It was approved for use in insulin pumps in October 2019 and for use in children with diabetes in January 2020.

The new approval for Lyumjev was based on data from a phase 3 trial, PRONTO-Pump-2. That trial, which included 432 participants with type 1 diabetes, confirmed the drug’s safety and efficacy when used in pumps.

The study met the primary endpoint of noninferiority in reduction of hemoglobin A1c from baseline to week 16, compared with insulin lispro (Humalog 100 units/mL). It was superior in both 1-hour and 2-hour postprandial glucose reduction when delivered 0-2 minutes before meals, according to a Lilly statement.

Patients who cannot afford the drug can go to www.insulinaffordability.com for assistance. Those with commercial insurance can also visit www.Lyumjev.com to access the Lyumjev Savings Card.

Lyumjev is available in several global markets, including Japan and the European Union, where it is also approved for use in insulin pumps.

A version of this article first appeared on Medscape.com.

Rhythmic brain signals that help encode memories also appear to influence blood sugar levels and may regulate the timing of the release of hormones, early, pre-clinical research shows.

“Our study is the first to show how clusters of brain cell firing in the hippocampus may directly regulate metabolism,” senior author György Buzsáki, MD, PhD, professor, department of neuroscience and physiology, NYU Grossman School of Medicine and NYU Langone Health, said in a news release.

“Evidence suggests that the brain evolved, for reasons of efficiency, to use the same signals to achieve two very different functions in terms of memory and hormonal regulation,” added corresponding author David Tingley, PhD, a post-doctoral scholar in Dr. Buzsáki’s lab.

Additional research may also reveal devices or therapies that can adjust the brain signals to lower blood sugar and improve memory, the researchers say.

The study was published online August 11 in Nature.

It’s recently been discovered that populations of hippocampal neurons fire within milliseconds of each other in cycles. This firing pattern is called a “sharp wave ripple” for the shape it takes when captured graphically by electroencephalogram.

In their study, Dr. Buzsáki, Dr. Tingley, and colleagues observed that clusters of sharp wave ripples recorded from the hippocampus of rats were “reliably” and rapidly, followed by decreases in blood sugar concentrations in the animals.

“This correlation was not dependent on circadian, ultradian, or meal-triggered fluctuations; it could be mimicked with optogenetically induced ripples in the hippocampus, but not in the parietal cortex, and was attenuated to chance levels by pharmacogenetically suppressing activity of the lateral septum (LS), the major conduit between the hippocampus and hypothalamus,” the researchers report.

These observations suggest that hippocampal sharp wave ripples may regulate the timing of the release of hormones, possibly including insulin, by the pancreas and liver, as well as other hormones by the pituitary gland, the researchers note.

As sharp wave ripples mostly occur during non-rapid eye movement sleep, the impact of sleep disturbance on sharp wave ripples may provide a mechanistic link between poor sleep and high blood sugar levels seen in type 2 diabetes, they suggest.

“There are a couple of experimental studies showing that if you deprive a young healthy person from sleep [for 48 hours], their glucose tolerance resembles” that of a person with diabetes, Dr. Buzsáki noted in an interview.

Moving forward, the researchers will seek to extend their theory that several hormones could be affected by nightly sharp wave ripples.

The research was funded by National Institutes of Health. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Rhythmic brain signals that help encode memories also appear to influence blood sugar levels and may regulate the timing of the release of hormones, early, pre-clinical research shows.

“Our study is the first to show how clusters of brain cell firing in the hippocampus may directly regulate metabolism,” senior author György Buzsáki, MD, PhD, professor, department of neuroscience and physiology, NYU Grossman School of Medicine and NYU Langone Health, said in a news release.

“Evidence suggests that the brain evolved, for reasons of efficiency, to use the same signals to achieve two very different functions in terms of memory and hormonal regulation,” added corresponding author David Tingley, PhD, a post-doctoral scholar in Dr. Buzsáki’s lab.

Additional research may also reveal devices or therapies that can adjust the brain signals to lower blood sugar and improve memory, the researchers say.

The study was published online August 11 in Nature.

It’s recently been discovered that populations of hippocampal neurons fire within milliseconds of each other in cycles. This firing pattern is called a “sharp wave ripple” for the shape it takes when captured graphically by electroencephalogram.

In their study, Dr. Buzsáki, Dr. Tingley, and colleagues observed that clusters of sharp wave ripples recorded from the hippocampus of rats were “reliably” and rapidly, followed by decreases in blood sugar concentrations in the animals.

“This correlation was not dependent on circadian, ultradian, or meal-triggered fluctuations; it could be mimicked with optogenetically induced ripples in the hippocampus, but not in the parietal cortex, and was attenuated to chance levels by pharmacogenetically suppressing activity of the lateral septum (LS), the major conduit between the hippocampus and hypothalamus,” the researchers report.

These observations suggest that hippocampal sharp wave ripples may regulate the timing of the release of hormones, possibly including insulin, by the pancreas and liver, as well as other hormones by the pituitary gland, the researchers note.

As sharp wave ripples mostly occur during non-rapid eye movement sleep, the impact of sleep disturbance on sharp wave ripples may provide a mechanistic link between poor sleep and high blood sugar levels seen in type 2 diabetes, they suggest.

“There are a couple of experimental studies showing that if you deprive a young healthy person from sleep [for 48 hours], their glucose tolerance resembles” that of a person with diabetes, Dr. Buzsáki noted in an interview.

Moving forward, the researchers will seek to extend their theory that several hormones could be affected by nightly sharp wave ripples.

The research was funded by National Institutes of Health. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Rhythmic brain signals that help encode memories also appear to influence blood sugar levels and may regulate the timing of the release of hormones, early, pre-clinical research shows.

“Our study is the first to show how clusters of brain cell firing in the hippocampus may directly regulate metabolism,” senior author György Buzsáki, MD, PhD, professor, department of neuroscience and physiology, NYU Grossman School of Medicine and NYU Langone Health, said in a news release.

“Evidence suggests that the brain evolved, for reasons of efficiency, to use the same signals to achieve two very different functions in terms of memory and hormonal regulation,” added corresponding author David Tingley, PhD, a post-doctoral scholar in Dr. Buzsáki’s lab.

Additional research may also reveal devices or therapies that can adjust the brain signals to lower blood sugar and improve memory, the researchers say.

The study was published online August 11 in Nature.

It’s recently been discovered that populations of hippocampal neurons fire within milliseconds of each other in cycles. This firing pattern is called a “sharp wave ripple” for the shape it takes when captured graphically by electroencephalogram.

In their study, Dr. Buzsáki, Dr. Tingley, and colleagues observed that clusters of sharp wave ripples recorded from the hippocampus of rats were “reliably” and rapidly, followed by decreases in blood sugar concentrations in the animals.

“This correlation was not dependent on circadian, ultradian, or meal-triggered fluctuations; it could be mimicked with optogenetically induced ripples in the hippocampus, but not in the parietal cortex, and was attenuated to chance levels by pharmacogenetically suppressing activity of the lateral septum (LS), the major conduit between the hippocampus and hypothalamus,” the researchers report.

These observations suggest that hippocampal sharp wave ripples may regulate the timing of the release of hormones, possibly including insulin, by the pancreas and liver, as well as other hormones by the pituitary gland, the researchers note.

As sharp wave ripples mostly occur during non-rapid eye movement sleep, the impact of sleep disturbance on sharp wave ripples may provide a mechanistic link between poor sleep and high blood sugar levels seen in type 2 diabetes, they suggest.

“There are a couple of experimental studies showing that if you deprive a young healthy person from sleep [for 48 hours], their glucose tolerance resembles” that of a person with diabetes, Dr. Buzsáki noted in an interview.

Moving forward, the researchers will seek to extend their theory that several hormones could be affected by nightly sharp wave ripples.

The research was funded by National Institutes of Health. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A diet rich in vegetables and low in carbs – a so-called low glycemic index (GI) diet – is associated with clinically significant benefits beyond those provided by existing medications for people with type 1 and type 2 diabetes, compared with a higher glycemic diet, findings from a new meta-analysis show.

marilyna/iStock/Getty Images Plus

“Although the effects were small, which is not surprising in clinical trials in nutrition, they were clinically meaningful improvements for which our certainty in the effects were moderate to high,” first author Laura Chiavaroli, PhD, of the department of nutritional sciences, Temerty Faculty of Medicine, University of Toronto, said in an interview.

The GI rates foods on the basis of how quickly they affect blood glucose levels.

Fruits, vegetables, and whole grains have a low GI. They also help to regulate blood sugar levels. Such foods are linked to a reduced risk for heart disease among people with diabetes.

But guidelines on this – such as those from the European Association for the Study of Diabetes – reflect research published more than 15 years ago, before several key trials were published.

Dr. Chiavaroli and colleagues identified 27 randomized controlled trials – the most recent of which was published in May 2021 – that involved a total of 1,617 adults with type 1 or 2 diabetes. For the patients in these trials, diabetes was moderately controlled with glucose-lowering drugs or insulin. All of the included trials examined the effects of a low GI diet or a low glycemic load (GL) diet for people with diabetes over a period 3 or more weeks. The majority of patients in the studies were overweight or had obesity, and they were largely middle-aged.

The meta-analysis, which included new data, was published Aug. 5 in The BMJ. The study “expands the number of relevant intermediate cardiometabolic outcomes, and assesses the certainty of the evidence using GRADE [grading of recommendations assessment, development, and evaluation],” Dr. Chiavaroli and colleagues noted.

“The available evidence provides a good indication of the likely benefit in this population and supports existing recommendations for the use of low GI dietary patterns in the management of diabetes,” they emphasized.
 

Improvements in A1c, fasting glucose, cholesterol, and triglycerides

Overall, compared with people who consumed diets with higher GI/GL ratings, for those who consumed lower glycemic diets, glycemic control was significantly improved, as reflected in A1c level, which was the primary outcome of the study (mean difference, –0.31%; P < .001).

This “would meet the threshold of ≥ 0.3% reduction in HbA1c proposed by the European Medicines Agency as clinically relevant for risk reduction of diabetic complications,” the authors noted.

Those who consumed low glycemic diets also showed improvements in secondary outcomes, including fasting glucose level, which was reduced by 0.36 mmol/L (–6.5 mg/dL), a 6% reduction in low-density cholesterol (LDL-C) (–0.17 mmol/L), and a fall in triglyceride levels (–0.09 mmol/L).

They also lost marginally more body weight, at –0.66 kg (–1.5 pounds). Body mass index was lower by –0.38, and inflammation was reduced (C-reactive protein, –.41 mg/L; all P < .05).

No significant differences were observed between the groups in blood insulin level, high-density lipoprotein cholesterol level, waist circumference, or blood pressure.

Three of the studies showed that participants developed a preference for the low GI diet. “In recent years, there has been a growing interest in whole-food plant-based diets, and there are more options, for example, for pulse-based products,” Dr. Chiavaroli said.

This meta-analysis should support the recommendation of the low-glycemic diet, particularly among people with diabetes, she reiterated.
 

Will larger randomized trial show effect on outcomes?

The authors noted, however, that to determine whether these small improvements in intermediate cardiometabolic risk factors observed with low GI diets translate to reductions in cardiovascular disease, nephropathy, and retinopathy among people with diabetes, larger randomized trials are needed.

One such trial, the Low Glycemic Index Diet for Type 2 Diabetics, includes 169 high-risk patients with type 2 diabetes and subclinical atherosclerosis. The investigators are evaluating the effect of a low GI diet on the progression of atherosclerosis, as assessed by vascular MRI over 3 years.

“We await the results,” they said.

The study received funding from the Diabetes and Nutrition Study Group of the European Association for the Study of Diabetes (EASD) as part of the development of the EASD Clinical Practice Guidelines for Nutrition Therapy. The study was also supported by the Canadian Institutes of Health Research through the Canada-wide Human Nutrition Trialists’ Network. The Diet, Digestive Tract, and Disease (3D) Center, which is funded through the Canada Foundation for Innovation and the Ministry of Research and Innovation’s Ontario Research Fund, provided the infrastructure for the study.

A version of this article first appeared on Medscape.com.

A diet rich in vegetables and low in carbs – a so-called low glycemic index (GI) diet – is associated with clinically significant benefits beyond those provided by existing medications for people with type 1 and type 2 diabetes, compared with a higher glycemic diet, findings from a new meta-analysis show.

marilyna/iStock/Getty Images Plus

“Although the effects were small, which is not surprising in clinical trials in nutrition, they were clinically meaningful improvements for which our certainty in the effects were moderate to high,” first author Laura Chiavaroli, PhD, of the department of nutritional sciences, Temerty Faculty of Medicine, University of Toronto, said in an interview.

The GI rates foods on the basis of how quickly they affect blood glucose levels.

Fruits, vegetables, and whole grains have a low GI. They also help to regulate blood sugar levels. Such foods are linked to a reduced risk for heart disease among people with diabetes.

But guidelines on this – such as those from the European Association for the Study of Diabetes – reflect research published more than 15 years ago, before several key trials were published.

Dr. Chiavaroli and colleagues identified 27 randomized controlled trials – the most recent of which was published in May 2021 – that involved a total of 1,617 adults with type 1 or 2 diabetes. For the patients in these trials, diabetes was moderately controlled with glucose-lowering drugs or insulin. All of the included trials examined the effects of a low GI diet or a low glycemic load (GL) diet for people with diabetes over a period 3 or more weeks. The majority of patients in the studies were overweight or had obesity, and they were largely middle-aged.

The meta-analysis, which included new data, was published Aug. 5 in The BMJ. The study “expands the number of relevant intermediate cardiometabolic outcomes, and assesses the certainty of the evidence using GRADE [grading of recommendations assessment, development, and evaluation],” Dr. Chiavaroli and colleagues noted.

“The available evidence provides a good indication of the likely benefit in this population and supports existing recommendations for the use of low GI dietary patterns in the management of diabetes,” they emphasized.
 

Improvements in A1c, fasting glucose, cholesterol, and triglycerides

Overall, compared with people who consumed diets with higher GI/GL ratings, for those who consumed lower glycemic diets, glycemic control was significantly improved, as reflected in A1c level, which was the primary outcome of the study (mean difference, –0.31%; P < .001).

This “would meet the threshold of ≥ 0.3% reduction in HbA1c proposed by the European Medicines Agency as clinically relevant for risk reduction of diabetic complications,” the authors noted.

Those who consumed low glycemic diets also showed improvements in secondary outcomes, including fasting glucose level, which was reduced by 0.36 mmol/L (–6.5 mg/dL), a 6% reduction in low-density cholesterol (LDL-C) (–0.17 mmol/L), and a fall in triglyceride levels (–0.09 mmol/L).

They also lost marginally more body weight, at –0.66 kg (–1.5 pounds). Body mass index was lower by –0.38, and inflammation was reduced (C-reactive protein, –.41 mg/L; all P < .05).

No significant differences were observed between the groups in blood insulin level, high-density lipoprotein cholesterol level, waist circumference, or blood pressure.

Three of the studies showed that participants developed a preference for the low GI diet. “In recent years, there has been a growing interest in whole-food plant-based diets, and there are more options, for example, for pulse-based products,” Dr. Chiavaroli said.

This meta-analysis should support the recommendation of the low-glycemic diet, particularly among people with diabetes, she reiterated.
 

Will larger randomized trial show effect on outcomes?

The authors noted, however, that to determine whether these small improvements in intermediate cardiometabolic risk factors observed with low GI diets translate to reductions in cardiovascular disease, nephropathy, and retinopathy among people with diabetes, larger randomized trials are needed.

One such trial, the Low Glycemic Index Diet for Type 2 Diabetics, includes 169 high-risk patients with type 2 diabetes and subclinical atherosclerosis. The investigators are evaluating the effect of a low GI diet on the progression of atherosclerosis, as assessed by vascular MRI over 3 years.

“We await the results,” they said.

The study received funding from the Diabetes and Nutrition Study Group of the European Association for the Study of Diabetes (EASD) as part of the development of the EASD Clinical Practice Guidelines for Nutrition Therapy. The study was also supported by the Canadian Institutes of Health Research through the Canada-wide Human Nutrition Trialists’ Network. The Diet, Digestive Tract, and Disease (3D) Center, which is funded through the Canada Foundation for Innovation and the Ministry of Research and Innovation’s Ontario Research Fund, provided the infrastructure for the study.

A version of this article first appeared on Medscape.com.

A diet rich in vegetables and low in carbs – a so-called low glycemic index (GI) diet – is associated with clinically significant benefits beyond those provided by existing medications for people with type 1 and type 2 diabetes, compared with a higher glycemic diet, findings from a new meta-analysis show.

marilyna/iStock/Getty Images Plus

“Although the effects were small, which is not surprising in clinical trials in nutrition, they were clinically meaningful improvements for which our certainty in the effects were moderate to high,” first author Laura Chiavaroli, PhD, of the department of nutritional sciences, Temerty Faculty of Medicine, University of Toronto, said in an interview.

The GI rates foods on the basis of how quickly they affect blood glucose levels.

Fruits, vegetables, and whole grains have a low GI. They also help to regulate blood sugar levels. Such foods are linked to a reduced risk for heart disease among people with diabetes.

But guidelines on this – such as those from the European Association for the Study of Diabetes – reflect research published more than 15 years ago, before several key trials were published.

Dr. Chiavaroli and colleagues identified 27 randomized controlled trials – the most recent of which was published in May 2021 – that involved a total of 1,617 adults with type 1 or 2 diabetes. For the patients in these trials, diabetes was moderately controlled with glucose-lowering drugs or insulin. All of the included trials examined the effects of a low GI diet or a low glycemic load (GL) diet for people with diabetes over a period 3 or more weeks. The majority of patients in the studies were overweight or had obesity, and they were largely middle-aged.

The meta-analysis, which included new data, was published Aug. 5 in The BMJ. The study “expands the number of relevant intermediate cardiometabolic outcomes, and assesses the certainty of the evidence using GRADE [grading of recommendations assessment, development, and evaluation],” Dr. Chiavaroli and colleagues noted.

“The available evidence provides a good indication of the likely benefit in this population and supports existing recommendations for the use of low GI dietary patterns in the management of diabetes,” they emphasized.
 

Improvements in A1c, fasting glucose, cholesterol, and triglycerides

Overall, compared with people who consumed diets with higher GI/GL ratings, for those who consumed lower glycemic diets, glycemic control was significantly improved, as reflected in A1c level, which was the primary outcome of the study (mean difference, –0.31%; P < .001).

This “would meet the threshold of ≥ 0.3% reduction in HbA1c proposed by the European Medicines Agency as clinically relevant for risk reduction of diabetic complications,” the authors noted.

Those who consumed low glycemic diets also showed improvements in secondary outcomes, including fasting glucose level, which was reduced by 0.36 mmol/L (–6.5 mg/dL), a 6% reduction in low-density cholesterol (LDL-C) (–0.17 mmol/L), and a fall in triglyceride levels (–0.09 mmol/L).

They also lost marginally more body weight, at –0.66 kg (–1.5 pounds). Body mass index was lower by –0.38, and inflammation was reduced (C-reactive protein, –.41 mg/L; all P < .05).

No significant differences were observed between the groups in blood insulin level, high-density lipoprotein cholesterol level, waist circumference, or blood pressure.

Three of the studies showed that participants developed a preference for the low GI diet. “In recent years, there has been a growing interest in whole-food plant-based diets, and there are more options, for example, for pulse-based products,” Dr. Chiavaroli said.

This meta-analysis should support the recommendation of the low-glycemic diet, particularly among people with diabetes, she reiterated.
 

Will larger randomized trial show effect on outcomes?

The authors noted, however, that to determine whether these small improvements in intermediate cardiometabolic risk factors observed with low GI diets translate to reductions in cardiovascular disease, nephropathy, and retinopathy among people with diabetes, larger randomized trials are needed.

One such trial, the Low Glycemic Index Diet for Type 2 Diabetics, includes 169 high-risk patients with type 2 diabetes and subclinical atherosclerosis. The investigators are evaluating the effect of a low GI diet on the progression of atherosclerosis, as assessed by vascular MRI over 3 years.

“We await the results,” they said.

The study received funding from the Diabetes and Nutrition Study Group of the European Association for the Study of Diabetes (EASD) as part of the development of the EASD Clinical Practice Guidelines for Nutrition Therapy. The study was also supported by the Canadian Institutes of Health Research through the Canada-wide Human Nutrition Trialists’ Network. The Diet, Digestive Tract, and Disease (3D) Center, which is funded through the Canada Foundation for Innovation and the Ministry of Research and Innovation’s Ontario Research Fund, provided the infrastructure for the study.

A version of this article first appeared on Medscape.com.

New research provides further evidence that a high body mass index (BMI) leads to depressed mood and poor well-being via social and physical factors.

Obesity and depression are “major global health challenges; our findings suggest that reducing obesity will lower depression and improve well-being,” co–lead author Jessica O’Loughlin, PhD student, University of Exeter Medical School, United Kingdom, told this news organization.

“Doctors should consider both the biological consequences of having a higher BMI as well as the social implications when treating patients with obesity in order to help reduce the odds of them developing depression,” Ms. O’Loughlin added.

The study was published online July 16 in Human Molecular Genetics.
 

Large body of evidence

A large body of evidence indicates that higher BMI leads to depression.

Ms. O’Loughlin and colleagues leveraged genetic data from more than 145,000 individuals in the UK Biobank and Mendelian randomization to determine whether the causal link between high BMI and depression is the result of psychosocial pathways, physical pathways, or both.

The analysis showed that a genetically determined 1 standard deviation higher BMI (4.6 kg/m²) was associated with higher likelihood of depression (odds ratio, 1.50; 95% confidence interval, 1.15-1.95) and lower well-being (beta, -0.15; 95% CI, -0.26 to -0.04).

Using genetics to distinguish metabolic and psychosocial effects, the results also indicate that, even in the absence of adverse metabolic effects, “higher adiposity remains causal to depression and lowers wellbeing,” the researchers report.

“We showed similar findings when looking at genetically predicted BMI and when using genetic variants that make you fatter but metabolically healthier (favorable adiposity genetic variants),” said Ms. O’Loughlin.

“Although we can’t tell which factor plays a bigger role in the adiposity-depression relationship, our analysis suggests that both physical and social factors (e.g., social stigma) play a role in the relationship between higher BMI and higher odds of depression,” she added.

In contrast, there was little evidence that higher BMI in the presence or absence of adverse metabolic consequences causes generalized anxiety disorder.

“Finding ways to support people to lose weight could benefit their mental health as well as their physical health,” co–lead author Francesco Casanova, PhD, with the University of Exeter, said in a statement.
 

Unexpected finding

Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York University, said that “multiple studies have shown a correlation between stress, obesity, inflammation, overall well-being, and psychiatric disorders, particularly depressive and anxiety disorders.”

He said this new study is important for three reasons.

“The first is the cohort size. There were over 145,000 participants involved in the study, which is significant and serves to make its conclusions stronger,” Dr. Ahmad noted.

“The second point is that the authors found that the correlation between higher adiposity and depression and lower well-being scores occurred even in patients without adverse metabolic effects,” he said in an interview.

“Of note, obesity significantly increases the risk of developing type 2 diabetes, hypertension, and a host of other illnesses as well as inflammatory conditions, which can all have a negative impact on quality of life. Consequently, these can contribute to depression as well as anxiety,” Dr. Ahmad added.

“Interestingly, what this study suggests is that even people without these additional stressors are reporting higher rates of depression and lower scores of well-being, while higher adiposity is the common denominator,” he noted.

“Third, the paper found little to no correlation between higher adiposity and generalized anxiety disorder. This comes as a complete surprise because anxiety and depression are very common comorbidities,” Dr. Ahmad said.

“Moreover, numerous studies as well as clinical data suggest that obesity leads to chronic inflammation, which in turn is associated with less favorable metabolic profiles, and that anxiety and depressive disorders may in some way be psychiatric manifestations of inflammation. To see one but not the other was quite an unexpected finding,” Dr. Ahmad said.

The study was funded by the Academy of Medical Sciences. Ms. O’Loughlin, Dr. Casanova, and Dr. Ahmad have disclosed no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

New research provides further evidence that a high body mass index (BMI) leads to depressed mood and poor well-being via social and physical factors.

Obesity and depression are “major global health challenges; our findings suggest that reducing obesity will lower depression and improve well-being,” co–lead author Jessica O’Loughlin, PhD student, University of Exeter Medical School, United Kingdom, told this news organization.

“Doctors should consider both the biological consequences of having a higher BMI as well as the social implications when treating patients with obesity in order to help reduce the odds of them developing depression,” Ms. O’Loughlin added.

The study was published online July 16 in Human Molecular Genetics.
 

Large body of evidence

A large body of evidence indicates that higher BMI leads to depression.

Ms. O’Loughlin and colleagues leveraged genetic data from more than 145,000 individuals in the UK Biobank and Mendelian randomization to determine whether the causal link between high BMI and depression is the result of psychosocial pathways, physical pathways, or both.

The analysis showed that a genetically determined 1 standard deviation higher BMI (4.6 kg/m²) was associated with higher likelihood of depression (odds ratio, 1.50; 95% confidence interval, 1.15-1.95) and lower well-being (beta, -0.15; 95% CI, -0.26 to -0.04).

Using genetics to distinguish metabolic and psychosocial effects, the results also indicate that, even in the absence of adverse metabolic effects, “higher adiposity remains causal to depression and lowers wellbeing,” the researchers report.

“We showed similar findings when looking at genetically predicted BMI and when using genetic variants that make you fatter but metabolically healthier (favorable adiposity genetic variants),” said Ms. O’Loughlin.

“Although we can’t tell which factor plays a bigger role in the adiposity-depression relationship, our analysis suggests that both physical and social factors (e.g., social stigma) play a role in the relationship between higher BMI and higher odds of depression,” she added.

In contrast, there was little evidence that higher BMI in the presence or absence of adverse metabolic consequences causes generalized anxiety disorder.

“Finding ways to support people to lose weight could benefit their mental health as well as their physical health,” co–lead author Francesco Casanova, PhD, with the University of Exeter, said in a statement.
 

Unexpected finding

Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York University, said that “multiple studies have shown a correlation between stress, obesity, inflammation, overall well-being, and psychiatric disorders, particularly depressive and anxiety disorders.”

He said this new study is important for three reasons.

“The first is the cohort size. There were over 145,000 participants involved in the study, which is significant and serves to make its conclusions stronger,” Dr. Ahmad noted.

“The second point is that the authors found that the correlation between higher adiposity and depression and lower well-being scores occurred even in patients without adverse metabolic effects,” he said in an interview.

“Of note, obesity significantly increases the risk of developing type 2 diabetes, hypertension, and a host of other illnesses as well as inflammatory conditions, which can all have a negative impact on quality of life. Consequently, these can contribute to depression as well as anxiety,” Dr. Ahmad added.

“Interestingly, what this study suggests is that even people without these additional stressors are reporting higher rates of depression and lower scores of well-being, while higher adiposity is the common denominator,” he noted.

“Third, the paper found little to no correlation between higher adiposity and generalized anxiety disorder. This comes as a complete surprise because anxiety and depression are very common comorbidities,” Dr. Ahmad said.

“Moreover, numerous studies as well as clinical data suggest that obesity leads to chronic inflammation, which in turn is associated with less favorable metabolic profiles, and that anxiety and depressive disorders may in some way be psychiatric manifestations of inflammation. To see one but not the other was quite an unexpected finding,” Dr. Ahmad said.

The study was funded by the Academy of Medical Sciences. Ms. O’Loughlin, Dr. Casanova, and Dr. Ahmad have disclosed no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

New research provides further evidence that a high body mass index (BMI) leads to depressed mood and poor well-being via social and physical factors.

Obesity and depression are “major global health challenges; our findings suggest that reducing obesity will lower depression and improve well-being,” co–lead author Jessica O’Loughlin, PhD student, University of Exeter Medical School, United Kingdom, told this news organization.

“Doctors should consider both the biological consequences of having a higher BMI as well as the social implications when treating patients with obesity in order to help reduce the odds of them developing depression,” Ms. O’Loughlin added.

The study was published online July 16 in Human Molecular Genetics.
 

Large body of evidence

A large body of evidence indicates that higher BMI leads to depression.

Ms. O’Loughlin and colleagues leveraged genetic data from more than 145,000 individuals in the UK Biobank and Mendelian randomization to determine whether the causal link between high BMI and depression is the result of psychosocial pathways, physical pathways, or both.

The analysis showed that a genetically determined 1 standard deviation higher BMI (4.6 kg/m²) was associated with higher likelihood of depression (odds ratio, 1.50; 95% confidence interval, 1.15-1.95) and lower well-being (beta, -0.15; 95% CI, -0.26 to -0.04).

Using genetics to distinguish metabolic and psychosocial effects, the results also indicate that, even in the absence of adverse metabolic effects, “higher adiposity remains causal to depression and lowers wellbeing,” the researchers report.

“We showed similar findings when looking at genetically predicted BMI and when using genetic variants that make you fatter but metabolically healthier (favorable adiposity genetic variants),” said Ms. O’Loughlin.

“Although we can’t tell which factor plays a bigger role in the adiposity-depression relationship, our analysis suggests that both physical and social factors (e.g., social stigma) play a role in the relationship between higher BMI and higher odds of depression,” she added.

In contrast, there was little evidence that higher BMI in the presence or absence of adverse metabolic consequences causes generalized anxiety disorder.

“Finding ways to support people to lose weight could benefit their mental health as well as their physical health,” co–lead author Francesco Casanova, PhD, with the University of Exeter, said in a statement.
 

Unexpected finding

Reached for comment, Samoon Ahmad, MD, professor, department of psychiatry, New York University, said that “multiple studies have shown a correlation between stress, obesity, inflammation, overall well-being, and psychiatric disorders, particularly depressive and anxiety disorders.”

He said this new study is important for three reasons.

“The first is the cohort size. There were over 145,000 participants involved in the study, which is significant and serves to make its conclusions stronger,” Dr. Ahmad noted.

“The second point is that the authors found that the correlation between higher adiposity and depression and lower well-being scores occurred even in patients without adverse metabolic effects,” he said in an interview.

“Of note, obesity significantly increases the risk of developing type 2 diabetes, hypertension, and a host of other illnesses as well as inflammatory conditions, which can all have a negative impact on quality of life. Consequently, these can contribute to depression as well as anxiety,” Dr. Ahmad added.

“Interestingly, what this study suggests is that even people without these additional stressors are reporting higher rates of depression and lower scores of well-being, while higher adiposity is the common denominator,” he noted.

“Third, the paper found little to no correlation between higher adiposity and generalized anxiety disorder. This comes as a complete surprise because anxiety and depression are very common comorbidities,” Dr. Ahmad said.

“Moreover, numerous studies as well as clinical data suggest that obesity leads to chronic inflammation, which in turn is associated with less favorable metabolic profiles, and that anxiety and depressive disorders may in some way be psychiatric manifestations of inflammation. To see one but not the other was quite an unexpected finding,” Dr. Ahmad said.

The study was funded by the Academy of Medical Sciences. Ms. O’Loughlin, Dr. Casanova, and Dr. Ahmad have disclosed no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

Study Overview

Objective. To update national trends in the treatment and risk factor control of diabetic patients from 1999 through 2018 in the US using data from the National Health and Nutrition Examination Survey (NHANES) with the goal of identifying population subgroups with the highest probability of having untreated risk factors.

Design. The authors conducted a cross-sectional analysis of data from NHANES focusing on adults with diabetes. They examined patient characteristics and medication use over time and estimated the prevalence of risk factor control and medication use. To minimize the effects of a small sample size, the survey years were pooled into 4-year intervals. The variables studied included glycated hemoglobin (HbA_1c), blood pressure, serum cholesterol, medication use, sociodemographic characteristics, and weight status. For statistical analysis, logistic and multinomial logistic regression models were used to examine factors associated with treatment in participants who did not achieve targets for glycemic, blood pressure, and lipid control. Temporal trends were estimated using 2-piece linear spline models with 1 knot at inflection points.

Setting and participants. The NHANES program began in the early 1960s to monitor the health of the US population. In 1999, the survey became a continuous program combining interviews and physical examinations. The survey examines a nationally representative sample of about 5000 persons each year. This study included 6653 participants who were nonpregnant, aged older than 20 years, reported a diagnosis of diabetes from a physician, and participated in NHANES from 1999 through 2018.

Main outcome measures. The main outcome measures were temporal trends in risk factor control (glycemic, blood pressure, or lipid levels) and medication use (glucose lowering, blood pressure lowering, or lipid lowering medications), and number as well as class of drug used, from 1999 through 2018 in diabetic adults from the US participating in NHANES.

Results. Sociodemographic characteristics of the studied diabetes population—The age and racial or ethnic distribution of participants with diabetes were stable from 1999 through 2018, whereas participants with a college degree, higher income, health insurance, obesity, or long-standing diabetes increased during the same period.

Trends in diabetes risk factor control—The trends for glycemic, blood pressure, and lipid control were nonlinear, with an inflection point around 2010. Glycemic control was defined as HbA_1c less than 7%, blood pressure was considered controlled if less than 140/90 mmHg, and lipid was controlled if non-HDL cholesterol level was less than 130 mg/dL. Although these chosen targets were based on the most recent clinical guidelines, the authors declared that they observed similar trends when alternative targets were used. The level of risk factor control improved in all diabetic patients from 1999 through 2010. However, the percentage of adult diabetic participants for whom glycemic control was achieved declined from 57.4% (95% CI, 52.9-61.8) in 2007-2010 to 50.5% (95% CI, 45.8-55.3) in 2015-2018. Blood pressure control was achieved in 74.2% of participants (95% CI, 70.7-77.4) in 2011-2014 but declined to 70.4% (95% CI, 66.7-73.8) in 2015-2018. Control in lipid levels improved during the entire study period; however, the rate of improvement heavily declined after 2007 with lipid target levels attained in 52.3% of participants (95% CI, 49.2-55.3) in 2007-2014 and 55.7% (95% CI, 50.8-60.5) in 2015-2018. Finally, the percentage of participants in whom targets for all 3 risk factors were simultaneously achieved plateaued after 2010 and was 22.2% (95% CI, 17.9-27.3) in 2015-2018.

Trends in diabetes treatment—The use of glucose lowering drugs increased from 74.1% in 1999-2002 to 82.7% in 2007-2010 and then stabilized. A shift toward a safer glucose lowering treatment choice was observed with a decline in the use of older glucose lowering medications such as sulfonylureas, which increases the risk of hypoglycemia, and an increase in the use of metformin, insulin, and newer agents such as sodium-glucose cotransporter 2 inhibitors.

Similarly, blood pressure lowering medication use rose from 1999-2002 to 2007-2010 and then stabilized, with increased use of first-line recommended treatments including angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers. Likewise, statin use rose from 28.4% in 1999-2002 to 56% in 2011-2014 and then stabilized. The total number of drugs used culminated in 2011-2014 with 60% of participants using more than 5 drugs and then leveled off to 57.2% in 2015-2018. Lastly, health insurance status and race or ethnicity impacted the likelihood of receiving monotherapy or combination drug therapy when targets for glycemic, blood pressure, or lipid control were not achieved.

Conclusion. Despite great progress in the control of diabetes and its associated risk factors between 1999 and 2010, this trend declined for glycemic and blood pressure control and leveled off for lipid control in adult NHANES participants with diabetes after 2010. First-line treatments for diabetes and associated risk factors remain underused, and treatment intensification may not be sufficiently considered in patients with uncontrolled risk factors despite clinical guideline recommendations. The findings of this study may portend a possible population-level increase in diabetes-related illnesses in the years to come.

Commentary

The thorough understanding of trends in management of diseases is critical to inform public health policies and planning. Well designed clinical studies heavily influence the development of public health policies and clinical guidelines, which in turn drive real-world clinical practice. In a recent analysis utilizing data from NHANES, Fang et al¹ showed evidence of a general shift toward less intensive treatment of diabetes, hypertension, and hypercholesterolemia in adults living in the US during the last decade.

Similarly, in a separate study using NHANES data collected between 1999 and 2018 published in JAMA just 2 weeks after the current report, Wang et al² confirms this declining trend in diabetes management with only 21.2% of diabetic adults simultaneously attaining glycemic, blood pressure, and lipid level targets during the same period. What led to the decline in more stringent risk factor and diabetes management since 2010 observed in these studies? One possible explanation, as suggested by Fang et al, is that major clinical trials from the late 2000s­—including Action to Control Cardiovascular Risk in Diabetes, UK Prospective Diabetes Study, Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation, and Veterans Affairs Diabetes Trial—that assessed the effects of intensive glycemic control (with target HbA_1c < 6.5%) found that intensive treatment of diabetes compared to standard care had no cardiovascular benefit albeit increasing the risk of hypoglycemia. Thus, these trial findings may have translated into suboptimal diabetes treatment observed in some NHANES participants. Wang et al propose that effective tailored approaches are needed to improve risk factor control in diabetic patients, such as enhance and maintain adherence to medications and healthy lifestyle behaviors, as well as better access to health care and therapeutic education.

The changes in recent trends in diabetes management have immense clinical implications. The authors of this study suggest a link between the recent relaxation of glycemic targets, as well as risk factor control, and a resurgence of diabetic complications such as lower limb amputation or stroke. Indeed, several recent studies indicate an upward trend or plateau in diabetic complications which had been decreasing in prevalence prior to 2010.³ For example, lower extremity amputation has surged by more than 25% between 2010 and 2015, especially in young and middle-aged adults.⁴ Among the arguments brought forward that this recent resurgence in amputations is directly linked to worsening glycemic control is the fact that between 2007 and 2010, when glucose levels were best controlled within the previous 30-year period, amputations were also at the lowest levels. Moreover, data from the Centers for Disease Control and Prevention also show a 55% increase in mortality (from 15.7 to 24.2 per 1000) among diabetic patients between 2010 and 2015.¹⁴ On the other hand, a growing number of studies show that an increase of inappropriate treatment intensification—reaching HbA_1c levels that are way below the recommended targets—is associated with adverse consequences in diabetic patients particularly in those aged more than 65 years.^5-7 These seemingly contradictory findings highlight the importance of a personalized and thoughtful approach to the management of diabetes and its risk factors. As an example, an increase in the use of newer and safer glucose lowering drugs (eg, sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and dipeptidyl peptidase 4 inhibitors) can help achieve better HbA_1c goals with a reduced risk of hypoglycemic episodes as recently shown by a Danish study.⁸ In this study, the authors concluded that the reduction of the rate of hypoglycemic episodes leading to hospitalization in Denmark was directly linked to the use of these safer and newer glucose lowering drugs.

A discussion on the specifics of trends in diabetes treatment and control must include considerations in older adults aged more than 65 years who constitute more than 40% of the diabetic population. Despite the high prevalence of diabetes in this vulnerable population, such data are still insufficient in the literature and are critically needed to inform public health policies and clinical guidelines. In epidemiological studies focusing on diabetic complications from the last 10 years, concerning increases have been observed in younger⁹ and middle-aged adults while remaining stable in older adults. However, the risk of hypoglycemia or severe hypoglycemia remains high in older adults living in nursing facilities, even in those with an elevated HbA_1c of greater than 8%.⁷ Moreover, in light of more relaxed HbA_1c treatment goals for older frail adults as recommended by international guidelines since 2010,^10,11 recent findings from the French GERODIAB cohort show an increased mortality (hazard ratio, 1.76) in type 2 diabetics aged 70 years and older with HbA_1c greater than or equal to 8.6%.¹² Similarly, a 5-year retrospective British study from 2018 which included patients aged 70 years and older, shows an increased overall mortality in those with HbA_1c greater than 8.5%.¹³ Taken together, further age-stratified analysis utilizing data from large cohort studies including NHANES may help to clarify national trends in diabetes treatment and risk factor control as well as diabetic complications specific to the geriatric population. By being better informed of such trends, clinicians could then develop treatment strategies that minimize complications (eg, hypoglycemia, falls) while achieving favorable outcomes (eg, reduce hyperglycemic emergencies, improve survival) in frail older patients.

Applications for Clinical Practice

The understanding of population-wide trends in diabetes control is critical to planning public health approaches for the prevention and treatment of this disease and its complications. In older adults, the high risk of hypoglycemic events and insufficient epidemiological data on trends of diabetes control hinder diabetes management. Personalized treatment targets taking into account geriatric syndromes and general health status, as well as multidisciplinary management involving endocrinologists, geriatricians, and clinical pharmacists, are necessary to optimize care in older adults with diabetes.

Study Overview

Objective. To update national trends in the treatment and risk factor control of diabetic patients from 1999 through 2018 in the US using data from the National Health and Nutrition Examination Survey (NHANES) with the goal of identifying population subgroups with the highest probability of having untreated risk factors.

Design. The authors conducted a cross-sectional analysis of data from NHANES focusing on adults with diabetes. They examined patient characteristics and medication use over time and estimated the prevalence of risk factor control and medication use. To minimize the effects of a small sample size, the survey years were pooled into 4-year intervals. The variables studied included glycated hemoglobin (HbA_1c), blood pressure, serum cholesterol, medication use, sociodemographic characteristics, and weight status. For statistical analysis, logistic and multinomial logistic regression models were used to examine factors associated with treatment in participants who did not achieve targets for glycemic, blood pressure, and lipid control. Temporal trends were estimated using 2-piece linear spline models with 1 knot at inflection points.

Setting and participants. The NHANES program began in the early 1960s to monitor the health of the US population. In 1999, the survey became a continuous program combining interviews and physical examinations. The survey examines a nationally representative sample of about 5000 persons each year. This study included 6653 participants who were nonpregnant, aged older than 20 years, reported a diagnosis of diabetes from a physician, and participated in NHANES from 1999 through 2018.

Main outcome measures. The main outcome measures were temporal trends in risk factor control (glycemic, blood pressure, or lipid levels) and medication use (glucose lowering, blood pressure lowering, or lipid lowering medications), and number as well as class of drug used, from 1999 through 2018 in diabetic adults from the US participating in NHANES.

Results. Sociodemographic characteristics of the studied diabetes population—The age and racial or ethnic distribution of participants with diabetes were stable from 1999 through 2018, whereas participants with a college degree, higher income, health insurance, obesity, or long-standing diabetes increased during the same period.

Trends in diabetes risk factor control—The trends for glycemic, blood pressure, and lipid control were nonlinear, with an inflection point around 2010. Glycemic control was defined as HbA_1c less than 7%, blood pressure was considered controlled if less than 140/90 mmHg, and lipid was controlled if non-HDL cholesterol level was less than 130 mg/dL. Although these chosen targets were based on the most recent clinical guidelines, the authors declared that they observed similar trends when alternative targets were used. The level of risk factor control improved in all diabetic patients from 1999 through 2010. However, the percentage of adult diabetic participants for whom glycemic control was achieved declined from 57.4% (95% CI, 52.9-61.8) in 2007-2010 to 50.5% (95% CI, 45.8-55.3) in 2015-2018. Blood pressure control was achieved in 74.2% of participants (95% CI, 70.7-77.4) in 2011-2014 but declined to 70.4% (95% CI, 66.7-73.8) in 2015-2018. Control in lipid levels improved during the entire study period; however, the rate of improvement heavily declined after 2007 with lipid target levels attained in 52.3% of participants (95% CI, 49.2-55.3) in 2007-2014 and 55.7% (95% CI, 50.8-60.5) in 2015-2018. Finally, the percentage of participants in whom targets for all 3 risk factors were simultaneously achieved plateaued after 2010 and was 22.2% (95% CI, 17.9-27.3) in 2015-2018.

Trends in diabetes treatment—The use of glucose lowering drugs increased from 74.1% in 1999-2002 to 82.7% in 2007-2010 and then stabilized. A shift toward a safer glucose lowering treatment choice was observed with a decline in the use of older glucose lowering medications such as sulfonylureas, which increases the risk of hypoglycemia, and an increase in the use of metformin, insulin, and newer agents such as sodium-glucose cotransporter 2 inhibitors.

Similarly, blood pressure lowering medication use rose from 1999-2002 to 2007-2010 and then stabilized, with increased use of first-line recommended treatments including angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers. Likewise, statin use rose from 28.4% in 1999-2002 to 56% in 2011-2014 and then stabilized. The total number of drugs used culminated in 2011-2014 with 60% of participants using more than 5 drugs and then leveled off to 57.2% in 2015-2018. Lastly, health insurance status and race or ethnicity impacted the likelihood of receiving monotherapy or combination drug therapy when targets for glycemic, blood pressure, or lipid control were not achieved.

Conclusion. Despite great progress in the control of diabetes and its associated risk factors between 1999 and 2010, this trend declined for glycemic and blood pressure control and leveled off for lipid control in adult NHANES participants with diabetes after 2010. First-line treatments for diabetes and associated risk factors remain underused, and treatment intensification may not be sufficiently considered in patients with uncontrolled risk factors despite clinical guideline recommendations. The findings of this study may portend a possible population-level increase in diabetes-related illnesses in the years to come.

Commentary

The thorough understanding of trends in management of diseases is critical to inform public health policies and planning. Well designed clinical studies heavily influence the development of public health policies and clinical guidelines, which in turn drive real-world clinical practice. In a recent analysis utilizing data from NHANES, Fang et al¹ showed evidence of a general shift toward less intensive treatment of diabetes, hypertension, and hypercholesterolemia in adults living in the US during the last decade.

Similarly, in a separate study using NHANES data collected between 1999 and 2018 published in JAMA just 2 weeks after the current report, Wang et al² confirms this declining trend in diabetes management with only 21.2% of diabetic adults simultaneously attaining glycemic, blood pressure, and lipid level targets during the same period. What led to the decline in more stringent risk factor and diabetes management since 2010 observed in these studies? One possible explanation, as suggested by Fang et al, is that major clinical trials from the late 2000s­—including Action to Control Cardiovascular Risk in Diabetes, UK Prospective Diabetes Study, Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation, and Veterans Affairs Diabetes Trial—that assessed the effects of intensive glycemic control (with target HbA_1c < 6.5%) found that intensive treatment of diabetes compared to standard care had no cardiovascular benefit albeit increasing the risk of hypoglycemia. Thus, these trial findings may have translated into suboptimal diabetes treatment observed in some NHANES participants. Wang et al propose that effective tailored approaches are needed to improve risk factor control in diabetic patients, such as enhance and maintain adherence to medications and healthy lifestyle behaviors, as well as better access to health care and therapeutic education.

The changes in recent trends in diabetes management have immense clinical implications. The authors of this study suggest a link between the recent relaxation of glycemic targets, as well as risk factor control, and a resurgence of diabetic complications such as lower limb amputation or stroke. Indeed, several recent studies indicate an upward trend or plateau in diabetic complications which had been decreasing in prevalence prior to 2010.³ For example, lower extremity amputation has surged by more than 25% between 2010 and 2015, especially in young and middle-aged adults.⁴ Among the arguments brought forward that this recent resurgence in amputations is directly linked to worsening glycemic control is the fact that between 2007 and 2010, when glucose levels were best controlled within the previous 30-year period, amputations were also at the lowest levels. Moreover, data from the Centers for Disease Control and Prevention also show a 55% increase in mortality (from 15.7 to 24.2 per 1000) among diabetic patients between 2010 and 2015.¹⁴ On the other hand, a growing number of studies show that an increase of inappropriate treatment intensification—reaching HbA_1c levels that are way below the recommended targets—is associated with adverse consequences in diabetic patients particularly in those aged more than 65 years.^5-7 These seemingly contradictory findings highlight the importance of a personalized and thoughtful approach to the management of diabetes and its risk factors. As an example, an increase in the use of newer and safer glucose lowering drugs (eg, sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and dipeptidyl peptidase 4 inhibitors) can help achieve better HbA_1c goals with a reduced risk of hypoglycemic episodes as recently shown by a Danish study.⁸ In this study, the authors concluded that the reduction of the rate of hypoglycemic episodes leading to hospitalization in Denmark was directly linked to the use of these safer and newer glucose lowering drugs.

A discussion on the specifics of trends in diabetes treatment and control must include considerations in older adults aged more than 65 years who constitute more than 40% of the diabetic population. Despite the high prevalence of diabetes in this vulnerable population, such data are still insufficient in the literature and are critically needed to inform public health policies and clinical guidelines. In epidemiological studies focusing on diabetic complications from the last 10 years, concerning increases have been observed in younger⁹ and middle-aged adults while remaining stable in older adults. However, the risk of hypoglycemia or severe hypoglycemia remains high in older adults living in nursing facilities, even in those with an elevated HbA_1c of greater than 8%.⁷ Moreover, in light of more relaxed HbA_1c treatment goals for older frail adults as recommended by international guidelines since 2010,^10,11 recent findings from the French GERODIAB cohort show an increased mortality (hazard ratio, 1.76) in type 2 diabetics aged 70 years and older with HbA_1c greater than or equal to 8.6%.¹² Similarly, a 5-year retrospective British study from 2018 which included patients aged 70 years and older, shows an increased overall mortality in those with HbA_1c greater than 8.5%.¹³ Taken together, further age-stratified analysis utilizing data from large cohort studies including NHANES may help to clarify national trends in diabetes treatment and risk factor control as well as diabetic complications specific to the geriatric population. By being better informed of such trends, clinicians could then develop treatment strategies that minimize complications (eg, hypoglycemia, falls) while achieving favorable outcomes (eg, reduce hyperglycemic emergencies, improve survival) in frail older patients.

Applications for Clinical Practice

The understanding of population-wide trends in diabetes control is critical to planning public health approaches for the prevention and treatment of this disease and its complications. In older adults, the high risk of hypoglycemic events and insufficient epidemiological data on trends of diabetes control hinder diabetes management. Personalized treatment targets taking into account geriatric syndromes and general health status, as well as multidisciplinary management involving endocrinologists, geriatricians, and clinical pharmacists, are necessary to optimize care in older adults with diabetes.

Study Overview

Objective. To update national trends in the treatment and risk factor control of diabetic patients from 1999 through 2018 in the US using data from the National Health and Nutrition Examination Survey (NHANES) with the goal of identifying population subgroups with the highest probability of having untreated risk factors.

Design. The authors conducted a cross-sectional analysis of data from NHANES focusing on adults with diabetes. They examined patient characteristics and medication use over time and estimated the prevalence of risk factor control and medication use. To minimize the effects of a small sample size, the survey years were pooled into 4-year intervals. The variables studied included glycated hemoglobin (HbA_1c), blood pressure, serum cholesterol, medication use, sociodemographic characteristics, and weight status. For statistical analysis, logistic and multinomial logistic regression models were used to examine factors associated with treatment in participants who did not achieve targets for glycemic, blood pressure, and lipid control. Temporal trends were estimated using 2-piece linear spline models with 1 knot at inflection points.

Setting and participants. The NHANES program began in the early 1960s to monitor the health of the US population. In 1999, the survey became a continuous program combining interviews and physical examinations. The survey examines a nationally representative sample of about 5000 persons each year. This study included 6653 participants who were nonpregnant, aged older than 20 years, reported a diagnosis of diabetes from a physician, and participated in NHANES from 1999 through 2018.

Main outcome measures. The main outcome measures were temporal trends in risk factor control (glycemic, blood pressure, or lipid levels) and medication use (glucose lowering, blood pressure lowering, or lipid lowering medications), and number as well as class of drug used, from 1999 through 2018 in diabetic adults from the US participating in NHANES.

Results. Sociodemographic characteristics of the studied diabetes population—The age and racial or ethnic distribution of participants with diabetes were stable from 1999 through 2018, whereas participants with a college degree, higher income, health insurance, obesity, or long-standing diabetes increased during the same period.

Trends in diabetes risk factor control—The trends for glycemic, blood pressure, and lipid control were nonlinear, with an inflection point around 2010. Glycemic control was defined as HbA_1c less than 7%, blood pressure was considered controlled if less than 140/90 mmHg, and lipid was controlled if non-HDL cholesterol level was less than 130 mg/dL. Although these chosen targets were based on the most recent clinical guidelines, the authors declared that they observed similar trends when alternative targets were used. The level of risk factor control improved in all diabetic patients from 1999 through 2010. However, the percentage of adult diabetic participants for whom glycemic control was achieved declined from 57.4% (95% CI, 52.9-61.8) in 2007-2010 to 50.5% (95% CI, 45.8-55.3) in 2015-2018. Blood pressure control was achieved in 74.2% of participants (95% CI, 70.7-77.4) in 2011-2014 but declined to 70.4% (95% CI, 66.7-73.8) in 2015-2018. Control in lipid levels improved during the entire study period; however, the rate of improvement heavily declined after 2007 with lipid target levels attained in 52.3% of participants (95% CI, 49.2-55.3) in 2007-2014 and 55.7% (95% CI, 50.8-60.5) in 2015-2018. Finally, the percentage of participants in whom targets for all 3 risk factors were simultaneously achieved plateaued after 2010 and was 22.2% (95% CI, 17.9-27.3) in 2015-2018.

Trends in diabetes treatment—The use of glucose lowering drugs increased from 74.1% in 1999-2002 to 82.7% in 2007-2010 and then stabilized. A shift toward a safer glucose lowering treatment choice was observed with a decline in the use of older glucose lowering medications such as sulfonylureas, which increases the risk of hypoglycemia, and an increase in the use of metformin, insulin, and newer agents such as sodium-glucose cotransporter 2 inhibitors.

Similarly, blood pressure lowering medication use rose from 1999-2002 to 2007-2010 and then stabilized, with increased use of first-line recommended treatments including angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers. Likewise, statin use rose from 28.4% in 1999-2002 to 56% in 2011-2014 and then stabilized. The total number of drugs used culminated in 2011-2014 with 60% of participants using more than 5 drugs and then leveled off to 57.2% in 2015-2018. Lastly, health insurance status and race or ethnicity impacted the likelihood of receiving monotherapy or combination drug therapy when targets for glycemic, blood pressure, or lipid control were not achieved.

Conclusion. Despite great progress in the control of diabetes and its associated risk factors between 1999 and 2010, this trend declined for glycemic and blood pressure control and leveled off for lipid control in adult NHANES participants with diabetes after 2010. First-line treatments for diabetes and associated risk factors remain underused, and treatment intensification may not be sufficiently considered in patients with uncontrolled risk factors despite clinical guideline recommendations. The findings of this study may portend a possible population-level increase in diabetes-related illnesses in the years to come.

Commentary

The thorough understanding of trends in management of diseases is critical to inform public health policies and planning. Well designed clinical studies heavily influence the development of public health policies and clinical guidelines, which in turn drive real-world clinical practice. In a recent analysis utilizing data from NHANES, Fang et al¹ showed evidence of a general shift toward less intensive treatment of diabetes, hypertension, and hypercholesterolemia in adults living in the US during the last decade.

Similarly, in a separate study using NHANES data collected between 1999 and 2018 published in JAMA just 2 weeks after the current report, Wang et al² confirms this declining trend in diabetes management with only 21.2% of diabetic adults simultaneously attaining glycemic, blood pressure, and lipid level targets during the same period. What led to the decline in more stringent risk factor and diabetes management since 2010 observed in these studies? One possible explanation, as suggested by Fang et al, is that major clinical trials from the late 2000s­—including Action to Control Cardiovascular Risk in Diabetes, UK Prospective Diabetes Study, Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation, and Veterans Affairs Diabetes Trial—that assessed the effects of intensive glycemic control (with target HbA_1c < 6.5%) found that intensive treatment of diabetes compared to standard care had no cardiovascular benefit albeit increasing the risk of hypoglycemia. Thus, these trial findings may have translated into suboptimal diabetes treatment observed in some NHANES participants. Wang et al propose that effective tailored approaches are needed to improve risk factor control in diabetic patients, such as enhance and maintain adherence to medications and healthy lifestyle behaviors, as well as better access to health care and therapeutic education.

The changes in recent trends in diabetes management have immense clinical implications. The authors of this study suggest a link between the recent relaxation of glycemic targets, as well as risk factor control, and a resurgence of diabetic complications such as lower limb amputation or stroke. Indeed, several recent studies indicate an upward trend or plateau in diabetic complications which had been decreasing in prevalence prior to 2010.³ For example, lower extremity amputation has surged by more than 25% between 2010 and 2015, especially in young and middle-aged adults.⁴ Among the arguments brought forward that this recent resurgence in amputations is directly linked to worsening glycemic control is the fact that between 2007 and 2010, when glucose levels were best controlled within the previous 30-year period, amputations were also at the lowest levels. Moreover, data from the Centers for Disease Control and Prevention also show a 55% increase in mortality (from 15.7 to 24.2 per 1000) among diabetic patients between 2010 and 2015.¹⁴ On the other hand, a growing number of studies show that an increase of inappropriate treatment intensification—reaching HbA_1c levels that are way below the recommended targets—is associated with adverse consequences in diabetic patients particularly in those aged more than 65 years.^5-7 These seemingly contradictory findings highlight the importance of a personalized and thoughtful approach to the management of diabetes and its risk factors. As an example, an increase in the use of newer and safer glucose lowering drugs (eg, sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and dipeptidyl peptidase 4 inhibitors) can help achieve better HbA_1c goals with a reduced risk of hypoglycemic episodes as recently shown by a Danish study.⁸ In this study, the authors concluded that the reduction of the rate of hypoglycemic episodes leading to hospitalization in Denmark was directly linked to the use of these safer and newer glucose lowering drugs.

A discussion on the specifics of trends in diabetes treatment and control must include considerations in older adults aged more than 65 years who constitute more than 40% of the diabetic population. Despite the high prevalence of diabetes in this vulnerable population, such data are still insufficient in the literature and are critically needed to inform public health policies and clinical guidelines. In epidemiological studies focusing on diabetic complications from the last 10 years, concerning increases have been observed in younger⁹ and middle-aged adults while remaining stable in older adults. However, the risk of hypoglycemia or severe hypoglycemia remains high in older adults living in nursing facilities, even in those with an elevated HbA_1c of greater than 8%.⁷ Moreover, in light of more relaxed HbA_1c treatment goals for older frail adults as recommended by international guidelines since 2010,^10,11 recent findings from the French GERODIAB cohort show an increased mortality (hazard ratio, 1.76) in type 2 diabetics aged 70 years and older with HbA_1c greater than or equal to 8.6%.¹² Similarly, a 5-year retrospective British study from 2018 which included patients aged 70 years and older, shows an increased overall mortality in those with HbA_1c greater than 8.5%.¹³ Taken together, further age-stratified analysis utilizing data from large cohort studies including NHANES may help to clarify national trends in diabetes treatment and risk factor control as well as diabetic complications specific to the geriatric population. By being better informed of such trends, clinicians could then develop treatment strategies that minimize complications (eg, hypoglycemia, falls) while achieving favorable outcomes (eg, reduce hyperglycemic emergencies, improve survival) in frail older patients.

Applications for Clinical Practice

The understanding of population-wide trends in diabetes control is critical to planning public health approaches for the prevention and treatment of this disease and its complications. In older adults, the high risk of hypoglycemic events and insufficient epidemiological data on trends of diabetes control hinder diabetes management. Personalized treatment targets taking into account geriatric syndromes and general health status, as well as multidisciplinary management involving endocrinologists, geriatricians, and clinical pharmacists, are necessary to optimize care in older adults with diabetes.

The streak of positive phase 3 trial results for the novel “twincretin” tirzepatide when treating patients with type 2 diabetes continued in a report in The Lancet on results from the SURPASS-3 trial, which compared weekly subcutaneous injections of tirzepatide against daily treatment with insulin degludec in patients inadequately controlled on metformin alone or on metformin plus a sodium-glucose cotransporter 2 inhibitor.

Despite positive results in SURPASS-3, as well as in four other pivotal trials that are in the process of releasing full results, the safety and efficacy picture of tirzepatide still includes several as-yet unresolved issues, including the true incidence rate of gastrointestinal adverse effects, the role these effects play in weight loss during tirzepatide treatment, and the drug’s effect on important endpoints beyond weight loss and glycemic control such as cardiovascular outcomes and renal function, said two Australian experts who coauthored a comment on the new SURPASS-3 report.

Tirzepatide is called a “twincretin” because the molecule acts as both a glucagonlike peptide–1 receptor agonist, the drug class that includes semaglutide (Ozempic, Rybelsus, Wegovy) and liraglutide (Saxenda, Victoza), and also as a glucose-dependent insulinotropic polypeptide (GIP). Trial results reported to date suggest that tirzepatide “might be more potent than available GLP-1 receptor agonists,” based on evidence of superior glycemic control it produced relative to semaglutide in results from the SURPASS-2 phase 3 trial reported in August 2021, wrote Christopher K. Rayner, MD, and Michael Horowitz, MD, in their comment.

Uncertainty about gastrointestinal adverse effects

“Limitations of SURPASS-3 include the relatively small number of Asian and Black” patients enrolled, “and an open-label design that carries a risk for bias” when tallying the incidence of gastrointestinal adverse effects, which the trial recorded based on self-reports by enrolled patients.

A better design would use validated questionnaires geared to discerning gastrointestinal symptoms like the ones used in trials involving patients with functional gastrointestinal disorders, wrote Dr. Rayner, a professor of gastroenterology at the University of Adelaide, and Dr. Horowitz, a professor at the same institution and also director of the endocrine and metabolic unit at Royal Adelaide Hospital.

This approach would “allow for more robust evaluation of whether gastrointestinal symptoms are associated with increased weight loss,” they proposed, a possible partial explanation for the weight loss of some patients treated with a GLP-1 receptor agonist.

Additional outstanding questions about tirzepatide include the contribution resulting from the drug’s stimulation of the GIP receptor, as well as the role of GLP-1 receptor stimulation by tirzepatide in slowing gastric emptying. And they also cite the still-unreported effects of tirzepatide on cardiovascular events, fatty liver disease, and kidney function, and its longer-term effects with chronic treatment beyond a year.

All five of the recently completed SURPASS trials ran for 40-52 weeks.

Tirzepatide surpasses insulin degludec’s glycemic control

SURPASS-3 enrolled 1,444 patients with type 2 diabetes at 122 sites in 13 countries during 2019. The study’s primary endpoint was mean change in hemoglobin A1c from baseline after 52 weeks on treatment. The results showed that the A1c reduction with tirzepatide treatment significantly exceeded the drop produced by insulin degludec by 0.59%, 0.86%, and 1.04%, respectively, across the three tirzepatide dosages tested in a dose-response fashion, according to the recent publication.

The most common treatment-emergent adverse effects were gastrointestinal, which decreased with continued treatment, and tirzepatide produced fewer episodes of hypoglycemia, compared with insulin degludec (Tresiba).

In addition to full reports now out from SURPASS-2 and SURPASS-3, researchers also recently published full primary results from SURPASS-1. Results from SURPASS-5 appeared in a poster presented at the American Diabetes Association scientific sessions in June 2021 but have not yet been published in a full report, and the primary results from SURPASS-4are expected in a report during the European Association for the Study of Diabetes in September 2021.

SURPASS-3 and the other trials of tirzepatide were funded by Lilly, the company developing the drug. Dr. Rayner has been an adviser to Allergen and Glyscend, and has received research funding from Sanofi and Novartis. Dr. Horowitz has received symposia fees from Lilly, as well as from AstraZeneca and Boehringer Ingelheim.

[email protected]

The streak of positive phase 3 trial results for the novel “twincretin” tirzepatide when treating patients with type 2 diabetes continued in a report in The Lancet on results from the SURPASS-3 trial, which compared weekly subcutaneous injections of tirzepatide against daily treatment with insulin degludec in patients inadequately controlled on metformin alone or on metformin plus a sodium-glucose cotransporter 2 inhibitor.

Despite positive results in SURPASS-3, as well as in four other pivotal trials that are in the process of releasing full results, the safety and efficacy picture of tirzepatide still includes several as-yet unresolved issues, including the true incidence rate of gastrointestinal adverse effects, the role these effects play in weight loss during tirzepatide treatment, and the drug’s effect on important endpoints beyond weight loss and glycemic control such as cardiovascular outcomes and renal function, said two Australian experts who coauthored a comment on the new SURPASS-3 report.

Tirzepatide is called a “twincretin” because the molecule acts as both a glucagonlike peptide–1 receptor agonist, the drug class that includes semaglutide (Ozempic, Rybelsus, Wegovy) and liraglutide (Saxenda, Victoza), and also as a glucose-dependent insulinotropic polypeptide (GIP). Trial results reported to date suggest that tirzepatide “might be more potent than available GLP-1 receptor agonists,” based on evidence of superior glycemic control it produced relative to semaglutide in results from the SURPASS-2 phase 3 trial reported in August 2021, wrote Christopher K. Rayner, MD, and Michael Horowitz, MD, in their comment.

Uncertainty about gastrointestinal adverse effects

“Limitations of SURPASS-3 include the relatively small number of Asian and Black” patients enrolled, “and an open-label design that carries a risk for bias” when tallying the incidence of gastrointestinal adverse effects, which the trial recorded based on self-reports by enrolled patients.

A better design would use validated questionnaires geared to discerning gastrointestinal symptoms like the ones used in trials involving patients with functional gastrointestinal disorders, wrote Dr. Rayner, a professor of gastroenterology at the University of Adelaide, and Dr. Horowitz, a professor at the same institution and also director of the endocrine and metabolic unit at Royal Adelaide Hospital.

This approach would “allow for more robust evaluation of whether gastrointestinal symptoms are associated with increased weight loss,” they proposed, a possible partial explanation for the weight loss of some patients treated with a GLP-1 receptor agonist.

Additional outstanding questions about tirzepatide include the contribution resulting from the drug’s stimulation of the GIP receptor, as well as the role of GLP-1 receptor stimulation by tirzepatide in slowing gastric emptying. And they also cite the still-unreported effects of tirzepatide on cardiovascular events, fatty liver disease, and kidney function, and its longer-term effects with chronic treatment beyond a year.

All five of the recently completed SURPASS trials ran for 40-52 weeks.

Tirzepatide surpasses insulin degludec’s glycemic control

SURPASS-3 enrolled 1,444 patients with type 2 diabetes at 122 sites in 13 countries during 2019. The study’s primary endpoint was mean change in hemoglobin A1c from baseline after 52 weeks on treatment. The results showed that the A1c reduction with tirzepatide treatment significantly exceeded the drop produced by insulin degludec by 0.59%, 0.86%, and 1.04%, respectively, across the three tirzepatide dosages tested in a dose-response fashion, according to the recent publication.

The most common treatment-emergent adverse effects were gastrointestinal, which decreased with continued treatment, and tirzepatide produced fewer episodes of hypoglycemia, compared with insulin degludec (Tresiba).

In addition to full reports now out from SURPASS-2 and SURPASS-3, researchers also recently published full primary results from SURPASS-1. Results from SURPASS-5 appeared in a poster presented at the American Diabetes Association scientific sessions in June 2021 but have not yet been published in a full report, and the primary results from SURPASS-4are expected in a report during the European Association for the Study of Diabetes in September 2021.

SURPASS-3 and the other trials of tirzepatide were funded by Lilly, the company developing the drug. Dr. Rayner has been an adviser to Allergen and Glyscend, and has received research funding from Sanofi and Novartis. Dr. Horowitz has received symposia fees from Lilly, as well as from AstraZeneca and Boehringer Ingelheim.

[email protected]

The streak of positive phase 3 trial results for the novel “twincretin” tirzepatide when treating patients with type 2 diabetes continued in a report in The Lancet on results from the SURPASS-3 trial, which compared weekly subcutaneous injections of tirzepatide against daily treatment with insulin degludec in patients inadequately controlled on metformin alone or on metformin plus a sodium-glucose cotransporter 2 inhibitor.

Despite positive results in SURPASS-3, as well as in four other pivotal trials that are in the process of releasing full results, the safety and efficacy picture of tirzepatide still includes several as-yet unresolved issues, including the true incidence rate of gastrointestinal adverse effects, the role these effects play in weight loss during tirzepatide treatment, and the drug’s effect on important endpoints beyond weight loss and glycemic control such as cardiovascular outcomes and renal function, said two Australian experts who coauthored a comment on the new SURPASS-3 report.

Tirzepatide is called a “twincretin” because the molecule acts as both a glucagonlike peptide–1 receptor agonist, the drug class that includes semaglutide (Ozempic, Rybelsus, Wegovy) and liraglutide (Saxenda, Victoza), and also as a glucose-dependent insulinotropic polypeptide (GIP). Trial results reported to date suggest that tirzepatide “might be more potent than available GLP-1 receptor agonists,” based on evidence of superior glycemic control it produced relative to semaglutide in results from the SURPASS-2 phase 3 trial reported in August 2021, wrote Christopher K. Rayner, MD, and Michael Horowitz, MD, in their comment.

Uncertainty about gastrointestinal adverse effects

“Limitations of SURPASS-3 include the relatively small number of Asian and Black” patients enrolled, “and an open-label design that carries a risk for bias” when tallying the incidence of gastrointestinal adverse effects, which the trial recorded based on self-reports by enrolled patients.

A better design would use validated questionnaires geared to discerning gastrointestinal symptoms like the ones used in trials involving patients with functional gastrointestinal disorders, wrote Dr. Rayner, a professor of gastroenterology at the University of Adelaide, and Dr. Horowitz, a professor at the same institution and also director of the endocrine and metabolic unit at Royal Adelaide Hospital.

This approach would “allow for more robust evaluation of whether gastrointestinal symptoms are associated with increased weight loss,” they proposed, a possible partial explanation for the weight loss of some patients treated with a GLP-1 receptor agonist.

Additional outstanding questions about tirzepatide include the contribution resulting from the drug’s stimulation of the GIP receptor, as well as the role of GLP-1 receptor stimulation by tirzepatide in slowing gastric emptying. And they also cite the still-unreported effects of tirzepatide on cardiovascular events, fatty liver disease, and kidney function, and its longer-term effects with chronic treatment beyond a year.

All five of the recently completed SURPASS trials ran for 40-52 weeks.

Tirzepatide surpasses insulin degludec’s glycemic control

SURPASS-3 enrolled 1,444 patients with type 2 diabetes at 122 sites in 13 countries during 2019. The study’s primary endpoint was mean change in hemoglobin A1c from baseline after 52 weeks on treatment. The results showed that the A1c reduction with tirzepatide treatment significantly exceeded the drop produced by insulin degludec by 0.59%, 0.86%, and 1.04%, respectively, across the three tirzepatide dosages tested in a dose-response fashion, according to the recent publication.

The most common treatment-emergent adverse effects were gastrointestinal, which decreased with continued treatment, and tirzepatide produced fewer episodes of hypoglycemia, compared with insulin degludec (Tresiba).

In addition to full reports now out from SURPASS-2 and SURPASS-3, researchers also recently published full primary results from SURPASS-1. Results from SURPASS-5 appeared in a poster presented at the American Diabetes Association scientific sessions in June 2021 but have not yet been published in a full report, and the primary results from SURPASS-4are expected in a report during the European Association for the Study of Diabetes in September 2021.

SURPASS-3 and the other trials of tirzepatide were funded by Lilly, the company developing the drug. Dr. Rayner has been an adviser to Allergen and Glyscend, and has received research funding from Sanofi and Novartis. Dr. Horowitz has received symposia fees from Lilly, as well as from AstraZeneca and Boehringer Ingelheim.

[email protected]

In the 2 decades from 1999 to 2018, ultraprocessed foods consistently accounted for the majority of energy intake by American young people, a large cross-sectional study of National Health and Nutrition Examination Survey (NHANES) data shows.

In young people aged 2-19 years, the estimated percentage of total energy from consumption of ultraprocessed foods increased from 61.4% to 67.0%, for a difference of 5.6% (95% confidence interval [CI] 3.5-7.7, P < .001 for trend), according to Lu Wang, PhD, MPH, a postdoctoral fellow at the Friedman School of Nutrition Science and Policy at Tufts University in Boston, and colleagues.

In contrast, total energy from non- or minimally processed foods decreased from 28.8% to 23.5% (difference −5.3%, 95% CI, −7.5 to −3.2, P < .001 for trend).

“The estimated percentage of energy consumed from ultraprocessed foods increased from 1999 to 2018, with an increasing trend in ready-to-heat and -eat mixed dishes and a decreasing trend in sugar-sweetened beverages,” the authors wrote. The report was published online Aug. 10 in JAMA.

The findings held regardless of the educational and socioeconomic status of the children’s parents.

Significant disparities by race and ethnicity emerged, however, with the ultraprocessed food phenomenon more marked in non-Hispanic Black youths and Mexican-American youths than in their non-Hispanic White counterparts. “Targeted marketing of junk foods toward racial/ethnic minority youths may partly contribute to such differences,” the authors wrote. “However, persistently lower consumption of ultraprocessed foods among Mexican-American youths may reflect more home cooking among Hispanic families.”

Among non-Hispanic Black youths consumption rose from 62.2% to 72.5% (difference 10.3%, 95% CI, 6.8-13.8) and among Mexican-American youths from 55.8% to 63.5% (difference 7.6%, 95% CI, 4.4-10.9). In non-Hispanic White youths intake rose from 63.4% to 68.6% (difference 5.2%, 95% CI, 2.1-8.3, P = .04 for trends).

In addition, a higher consumption of ultraprocessed foods among school-aged youths than among preschool children aged 2-5 years may reflect increased marketing, availability, and selection of ultraprocessed foods for older youths, the authors noted.

Food processing, with its potential adverse effects, may need to be considered as a food dimension in addition to nutrients and food groups in future dietary recommendations and food policies, they added.

“An increasing number of studies are showing a link between ultraprocessed food consumption and adverse health outcomes in children,” corresponding author Fang Fang Zhang, MD, PhD, Neely Family Professor and associate professor at Tufts’ Friedman School of Nutrition Science and Policy, said in an interview. “Health care providers can play a larger role in encouraging patients – and their parents – to replace unhealthy ultraprocessed foods such as ultraprocessed sweet bakery products with healthy unprocessed or minimally processed foods in their diet such as less processed whole grains. “

In Dr. Zhang’s view, teachers also have a part to play in promoting nutrition literacy. “Schools can play an important role in empowering children with knowledge and skills to make healthy food choices,” she said. “Nutrition literacy should be an integral part of the health education curriculum in all K-12 schools.”

Commenting on the study but not involved in it, Michelle Katzow, MD, a pediatrician/obesity medicine specialist and assistant professor at the Feinstein Institutes for Medical Research in Manhasset, N.Y., said the work highlights an often overlooked aspect of the modern American diet that may well be contributing to poor health outcomes in young people.

“It suggests that even as the science advances and we learn more about the adverse health effects of ultraprocessed foods, public health efforts to improve nutrition and food quality in children have not been successful,” she said in an interview. “This is because it is so hard for public health advocates to compete with the food industry, which stands to really benefit financially from hooking kids on processed foods that are not good for their health.”

Dr. Katzow added that the observed racial/ethnic disparities are not surprising in light of a growing body of evidence that racism exists in food marketing. “We need to put forward policies that regulate the food industry, particularly in relation to its most susceptible targets, our kids.”
 

Study details

The serial cross-sectional analysis used 24-hour dietary recall data from a nationally representative sample from 10 NHANES cycles for the range of 1999-2000 to 2017-2018. The weighted mean age of the cohort was 10.7 years and 49.1% were girls.

Among the subgroups of ultraprocessed foods, the estimated percentage of energy from ready-to-heat and ready-to-eat mixed dishes increased from 2.2% to 11.2% (difference 8.9%; 95%, CI, 7.7-10.2).

Energy from sweets and sweet snacks increased from 10.7% to 12.9% (difference 2.3%; 95% CI, 1.0-3.6), but the estimated percentage of energy decreased for sugar-sweetened beverages from 10.8% to 5.3% (difference −5.5%; 95% CI, −6.5 to −4.5).

In other categories, estimated energy intake from processed fats and oils, condiments, and sauces fell from 7.1% to 4.0% (difference −3.1%; 95% CI, −3.7 to −2.6, all P < .05 for trend).

Not surprisingly, ultraprocessed foods had an overall poorer nutrient profile than that of nonultraprocessed, although they often contained less saturated fat, and they also contained more carbohydrates, mostly from low-quality sources with added sugars and low levels of dietary fiber and protein.

And despite a higher total folate content in ultraprocessed foods because of fortification, higher-level consumers took in less total folate owing to their lower consumption of whole foods.

The authors cautioned that in addition to poor nutrient profiles, processing itself may harm health by changing the physical structure and chemical composition of food, which could lead to elevated glycemic response and reduced satiety. Furthermore, recent research has linked food additives such as emulsifiers, stabilizers, and artificial sweeteners to adverse metabolomic effects and obesity risk. Pointing to the recent success of efforts to reduce consumption of sugary beverages, Dr. Zhang said, “We need to mobilize the same energy and level of commitment when it comes to other unhealthy ultraprocessed foods such as cakes, cookies, doughnuts, and brownies.”

The trends identified by the Tufts study “are concerning and potentially have major public health significance,” according to an accompanying JAMA editorial.

“Better dietary assessment methods are needed to document trends and understand the unique role of ultraprocessed foods to inform future evidence-based policy and dietary recommendations,” wrote Katie A. Meyer, ScD, and Lindsey Smith Taillie, PhD, of the Gillings School of Global Public Health at the University of North Carolina in Chapel Hill.

The editorialists share the authors’ view that “a conceptual advancement would be to consider the level and characteristics of processing as just one of multiple dimensions (including nutrients and food groups) used to classify foods as healthy or unhealthy.” They pointed out that the Pan American Health Organization already recommends targeting products that are ultraprocessed and high in concerning add-in nutrients.

They cautioned, however, that the classification of ultraprocessed foods will not be easy because it requires data on a full list of ingredients, and the effects of processing generally cannot be separated from the composite nutrients of ultraprocessed foods.

This presents a challenge for national food consumption research “given that most large epidemiological studies rely on food frequency questionnaires that lack the information necessary to classify processing levels,” they wrote.

This study was supported by the National Institutes of Health and the São Paulo Research Foundation. Coauthor Dariush Mozaffarian, MD, a cardiologist at Tufts University, disclosed support from the Bill & Melinda Gates Foundation, the National Institutes of Health, and the Rockefeller Foundation as well as personal fees from several commercial companies. He has served on several scientific advisory boards and received royalties from UpToDate, all outside of the submitted work. Dr. Meyer reported a grant from choline manufacturer Balchem. Dr. Taillie reported funding from Bloomberg Philanthropies. Dr. Zhang had no disclosures. Dr. Katzow disclosed no competing interests.

In the 2 decades from 1999 to 2018, ultraprocessed foods consistently accounted for the majority of energy intake by American young people, a large cross-sectional study of National Health and Nutrition Examination Survey (NHANES) data shows.

In young people aged 2-19 years, the estimated percentage of total energy from consumption of ultraprocessed foods increased from 61.4% to 67.0%, for a difference of 5.6% (95% confidence interval [CI] 3.5-7.7, P < .001 for trend), according to Lu Wang, PhD, MPH, a postdoctoral fellow at the Friedman School of Nutrition Science and Policy at Tufts University in Boston, and colleagues.

In contrast, total energy from non- or minimally processed foods decreased from 28.8% to 23.5% (difference −5.3%, 95% CI, −7.5 to −3.2, P < .001 for trend).

“The estimated percentage of energy consumed from ultraprocessed foods increased from 1999 to 2018, with an increasing trend in ready-to-heat and -eat mixed dishes and a decreasing trend in sugar-sweetened beverages,” the authors wrote. The report was published online Aug. 10 in JAMA.

The findings held regardless of the educational and socioeconomic status of the children’s parents.

Significant disparities by race and ethnicity emerged, however, with the ultraprocessed food phenomenon more marked in non-Hispanic Black youths and Mexican-American youths than in their non-Hispanic White counterparts. “Targeted marketing of junk foods toward racial/ethnic minority youths may partly contribute to such differences,” the authors wrote. “However, persistently lower consumption of ultraprocessed foods among Mexican-American youths may reflect more home cooking among Hispanic families.”

Among non-Hispanic Black youths consumption rose from 62.2% to 72.5% (difference 10.3%, 95% CI, 6.8-13.8) and among Mexican-American youths from 55.8% to 63.5% (difference 7.6%, 95% CI, 4.4-10.9). In non-Hispanic White youths intake rose from 63.4% to 68.6% (difference 5.2%, 95% CI, 2.1-8.3, P = .04 for trends).

In addition, a higher consumption of ultraprocessed foods among school-aged youths than among preschool children aged 2-5 years may reflect increased marketing, availability, and selection of ultraprocessed foods for older youths, the authors noted.

Food processing, with its potential adverse effects, may need to be considered as a food dimension in addition to nutrients and food groups in future dietary recommendations and food policies, they added.

“An increasing number of studies are showing a link between ultraprocessed food consumption and adverse health outcomes in children,” corresponding author Fang Fang Zhang, MD, PhD, Neely Family Professor and associate professor at Tufts’ Friedman School of Nutrition Science and Policy, said in an interview. “Health care providers can play a larger role in encouraging patients – and their parents – to replace unhealthy ultraprocessed foods such as ultraprocessed sweet bakery products with healthy unprocessed or minimally processed foods in their diet such as less processed whole grains. “

In Dr. Zhang’s view, teachers also have a part to play in promoting nutrition literacy. “Schools can play an important role in empowering children with knowledge and skills to make healthy food choices,” she said. “Nutrition literacy should be an integral part of the health education curriculum in all K-12 schools.”

Commenting on the study but not involved in it, Michelle Katzow, MD, a pediatrician/obesity medicine specialist and assistant professor at the Feinstein Institutes for Medical Research in Manhasset, N.Y., said the work highlights an often overlooked aspect of the modern American diet that may well be contributing to poor health outcomes in young people.

“It suggests that even as the science advances and we learn more about the adverse health effects of ultraprocessed foods, public health efforts to improve nutrition and food quality in children have not been successful,” she said in an interview. “This is because it is so hard for public health advocates to compete with the food industry, which stands to really benefit financially from hooking kids on processed foods that are not good for their health.”

Dr. Katzow added that the observed racial/ethnic disparities are not surprising in light of a growing body of evidence that racism exists in food marketing. “We need to put forward policies that regulate the food industry, particularly in relation to its most susceptible targets, our kids.”
 

Study details

The serial cross-sectional analysis used 24-hour dietary recall data from a nationally representative sample from 10 NHANES cycles for the range of 1999-2000 to 2017-2018. The weighted mean age of the cohort was 10.7 years and 49.1% were girls.

Among the subgroups of ultraprocessed foods, the estimated percentage of energy from ready-to-heat and ready-to-eat mixed dishes increased from 2.2% to 11.2% (difference 8.9%; 95%, CI, 7.7-10.2).

Energy from sweets and sweet snacks increased from 10.7% to 12.9% (difference 2.3%; 95% CI, 1.0-3.6), but the estimated percentage of energy decreased for sugar-sweetened beverages from 10.8% to 5.3% (difference −5.5%; 95% CI, −6.5 to −4.5).

In other categories, estimated energy intake from processed fats and oils, condiments, and sauces fell from 7.1% to 4.0% (difference −3.1%; 95% CI, −3.7 to −2.6, all P < .05 for trend).

Not surprisingly, ultraprocessed foods had an overall poorer nutrient profile than that of nonultraprocessed, although they often contained less saturated fat, and they also contained more carbohydrates, mostly from low-quality sources with added sugars and low levels of dietary fiber and protein.

And despite a higher total folate content in ultraprocessed foods because of fortification, higher-level consumers took in less total folate owing to their lower consumption of whole foods.

The authors cautioned that in addition to poor nutrient profiles, processing itself may harm health by changing the physical structure and chemical composition of food, which could lead to elevated glycemic response and reduced satiety. Furthermore, recent research has linked food additives such as emulsifiers, stabilizers, and artificial sweeteners to adverse metabolomic effects and obesity risk. Pointing to the recent success of efforts to reduce consumption of sugary beverages, Dr. Zhang said, “We need to mobilize the same energy and level of commitment when it comes to other unhealthy ultraprocessed foods such as cakes, cookies, doughnuts, and brownies.”

The trends identified by the Tufts study “are concerning and potentially have major public health significance,” according to an accompanying JAMA editorial.

“Better dietary assessment methods are needed to document trends and understand the unique role of ultraprocessed foods to inform future evidence-based policy and dietary recommendations,” wrote Katie A. Meyer, ScD, and Lindsey Smith Taillie, PhD, of the Gillings School of Global Public Health at the University of North Carolina in Chapel Hill.

The editorialists share the authors’ view that “a conceptual advancement would be to consider the level and characteristics of processing as just one of multiple dimensions (including nutrients and food groups) used to classify foods as healthy or unhealthy.” They pointed out that the Pan American Health Organization already recommends targeting products that are ultraprocessed and high in concerning add-in nutrients.

They cautioned, however, that the classification of ultraprocessed foods will not be easy because it requires data on a full list of ingredients, and the effects of processing generally cannot be separated from the composite nutrients of ultraprocessed foods.

This presents a challenge for national food consumption research “given that most large epidemiological studies rely on food frequency questionnaires that lack the information necessary to classify processing levels,” they wrote.

This study was supported by the National Institutes of Health and the São Paulo Research Foundation. Coauthor Dariush Mozaffarian, MD, a cardiologist at Tufts University, disclosed support from the Bill & Melinda Gates Foundation, the National Institutes of Health, and the Rockefeller Foundation as well as personal fees from several commercial companies. He has served on several scientific advisory boards and received royalties from UpToDate, all outside of the submitted work. Dr. Meyer reported a grant from choline manufacturer Balchem. Dr. Taillie reported funding from Bloomberg Philanthropies. Dr. Zhang had no disclosures. Dr. Katzow disclosed no competing interests.

In the 2 decades from 1999 to 2018, ultraprocessed foods consistently accounted for the majority of energy intake by American young people, a large cross-sectional study of National Health and Nutrition Examination Survey (NHANES) data shows.

In young people aged 2-19 years, the estimated percentage of total energy from consumption of ultraprocessed foods increased from 61.4% to 67.0%, for a difference of 5.6% (95% confidence interval [CI] 3.5-7.7, P < .001 for trend), according to Lu Wang, PhD, MPH, a postdoctoral fellow at the Friedman School of Nutrition Science and Policy at Tufts University in Boston, and colleagues.

In contrast, total energy from non- or minimally processed foods decreased from 28.8% to 23.5% (difference −5.3%, 95% CI, −7.5 to −3.2, P < .001 for trend).

“The estimated percentage of energy consumed from ultraprocessed foods increased from 1999 to 2018, with an increasing trend in ready-to-heat and -eat mixed dishes and a decreasing trend in sugar-sweetened beverages,” the authors wrote. The report was published online Aug. 10 in JAMA.

The findings held regardless of the educational and socioeconomic status of the children’s parents.

Significant disparities by race and ethnicity emerged, however, with the ultraprocessed food phenomenon more marked in non-Hispanic Black youths and Mexican-American youths than in their non-Hispanic White counterparts. “Targeted marketing of junk foods toward racial/ethnic minority youths may partly contribute to such differences,” the authors wrote. “However, persistently lower consumption of ultraprocessed foods among Mexican-American youths may reflect more home cooking among Hispanic families.”

Among non-Hispanic Black youths consumption rose from 62.2% to 72.5% (difference 10.3%, 95% CI, 6.8-13.8) and among Mexican-American youths from 55.8% to 63.5% (difference 7.6%, 95% CI, 4.4-10.9). In non-Hispanic White youths intake rose from 63.4% to 68.6% (difference 5.2%, 95% CI, 2.1-8.3, P = .04 for trends).

In addition, a higher consumption of ultraprocessed foods among school-aged youths than among preschool children aged 2-5 years may reflect increased marketing, availability, and selection of ultraprocessed foods for older youths, the authors noted.

Food processing, with its potential adverse effects, may need to be considered as a food dimension in addition to nutrients and food groups in future dietary recommendations and food policies, they added.

“An increasing number of studies are showing a link between ultraprocessed food consumption and adverse health outcomes in children,” corresponding author Fang Fang Zhang, MD, PhD, Neely Family Professor and associate professor at Tufts’ Friedman School of Nutrition Science and Policy, said in an interview. “Health care providers can play a larger role in encouraging patients – and their parents – to replace unhealthy ultraprocessed foods such as ultraprocessed sweet bakery products with healthy unprocessed or minimally processed foods in their diet such as less processed whole grains. “

In Dr. Zhang’s view, teachers also have a part to play in promoting nutrition literacy. “Schools can play an important role in empowering children with knowledge and skills to make healthy food choices,” she said. “Nutrition literacy should be an integral part of the health education curriculum in all K-12 schools.”

Commenting on the study but not involved in it, Michelle Katzow, MD, a pediatrician/obesity medicine specialist and assistant professor at the Feinstein Institutes for Medical Research in Manhasset, N.Y., said the work highlights an often overlooked aspect of the modern American diet that may well be contributing to poor health outcomes in young people.

“It suggests that even as the science advances and we learn more about the adverse health effects of ultraprocessed foods, public health efforts to improve nutrition and food quality in children have not been successful,” she said in an interview. “This is because it is so hard for public health advocates to compete with the food industry, which stands to really benefit financially from hooking kids on processed foods that are not good for their health.”

Dr. Katzow added that the observed racial/ethnic disparities are not surprising in light of a growing body of evidence that racism exists in food marketing. “We need to put forward policies that regulate the food industry, particularly in relation to its most susceptible targets, our kids.”
 

Study details

The serial cross-sectional analysis used 24-hour dietary recall data from a nationally representative sample from 10 NHANES cycles for the range of 1999-2000 to 2017-2018. The weighted mean age of the cohort was 10.7 years and 49.1% were girls.

Among the subgroups of ultraprocessed foods, the estimated percentage of energy from ready-to-heat and ready-to-eat mixed dishes increased from 2.2% to 11.2% (difference 8.9%; 95%, CI, 7.7-10.2).

Energy from sweets and sweet snacks increased from 10.7% to 12.9% (difference 2.3%; 95% CI, 1.0-3.6), but the estimated percentage of energy decreased for sugar-sweetened beverages from 10.8% to 5.3% (difference −5.5%; 95% CI, −6.5 to −4.5).

In other categories, estimated energy intake from processed fats and oils, condiments, and sauces fell from 7.1% to 4.0% (difference −3.1%; 95% CI, −3.7 to −2.6, all P < .05 for trend).

Not surprisingly, ultraprocessed foods had an overall poorer nutrient profile than that of nonultraprocessed, although they often contained less saturated fat, and they also contained more carbohydrates, mostly from low-quality sources with added sugars and low levels of dietary fiber and protein.

And despite a higher total folate content in ultraprocessed foods because of fortification, higher-level consumers took in less total folate owing to their lower consumption of whole foods.

The authors cautioned that in addition to poor nutrient profiles, processing itself may harm health by changing the physical structure and chemical composition of food, which could lead to elevated glycemic response and reduced satiety. Furthermore, recent research has linked food additives such as emulsifiers, stabilizers, and artificial sweeteners to adverse metabolomic effects and obesity risk. Pointing to the recent success of efforts to reduce consumption of sugary beverages, Dr. Zhang said, “We need to mobilize the same energy and level of commitment when it comes to other unhealthy ultraprocessed foods such as cakes, cookies, doughnuts, and brownies.”

The trends identified by the Tufts study “are concerning and potentially have major public health significance,” according to an accompanying JAMA editorial.

“Better dietary assessment methods are needed to document trends and understand the unique role of ultraprocessed foods to inform future evidence-based policy and dietary recommendations,” wrote Katie A. Meyer, ScD, and Lindsey Smith Taillie, PhD, of the Gillings School of Global Public Health at the University of North Carolina in Chapel Hill.

The editorialists share the authors’ view that “a conceptual advancement would be to consider the level and characteristics of processing as just one of multiple dimensions (including nutrients and food groups) used to classify foods as healthy or unhealthy.” They pointed out that the Pan American Health Organization already recommends targeting products that are ultraprocessed and high in concerning add-in nutrients.

They cautioned, however, that the classification of ultraprocessed foods will not be easy because it requires data on a full list of ingredients, and the effects of processing generally cannot be separated from the composite nutrients of ultraprocessed foods.

This presents a challenge for national food consumption research “given that most large epidemiological studies rely on food frequency questionnaires that lack the information necessary to classify processing levels,” they wrote.

This study was supported by the National Institutes of Health and the São Paulo Research Foundation. Coauthor Dariush Mozaffarian, MD, a cardiologist at Tufts University, disclosed support from the Bill & Melinda Gates Foundation, the National Institutes of Health, and the Rockefeller Foundation as well as personal fees from several commercial companies. He has served on several scientific advisory boards and received royalties from UpToDate, all outside of the submitted work. Dr. Meyer reported a grant from choline manufacturer Balchem. Dr. Taillie reported funding from Bloomberg Philanthropies. Dr. Zhang had no disclosures. Dr. Katzow disclosed no competing interests.

Asymptomatic pregnant women with no previous diagnosis of type 1 or 2 diabetes should be screened for gestational diabetes at 24 weeks’ gestation or later, according to an updated recommendation from the U.S. Preventive Services Task Force.

Pregnant individuals who develop gestational diabetes are at increased risk for complications including preeclampsia, fetal macrosomia, and neonatal hypoglycemia, as well as negative long-term outcomes for themselves and their children, wrote lead author Karina W. Davidson, PhD, of Feinstein Institute for Medical Research, Manhasset, N.Y., and colleagues. The statement was published online in JAMA.

The B recommendation and I statement reflect “moderate certainty” that current evidence supports the recommendation in terms of harms versus benefits, and is consistent with the 2014 USPSTF recommendation.

The statement calls for a one-time screening using a glucose tolerance test at or after 24 weeks’ gestation. Although most screening in the United States takes place prior to 28 weeks’ gestation, it can be performed later in patients who begin prenatal care after 28 weeks’ gestation, according to the statement. Data on the harms and benefits of gestational diabetes screening prior to 24 weeks’ gestation are limited, the authors noted. Gestational diabetes was defined as diabetes that develops during pregnancy that is not clearly overt diabetes.

To update the 2014 recommendation, the USPSTF commissioned a systematic review. In 45 prospective studies on the accuracy of gestational diabetes screening, several tests, included oral glucose challenge test, oral glucose tolerance test, and fasting plasma glucose using either a one- or two-step approach were accurate detectors of gestational diabetes; therefore, the USPSTF does not recommend a specific test.

In 13 trials on the impact of treating gestational diabetes on intermediate and health outcomes, treatment was associated with a reduced risk of outcomes, including primary cesarean delivery (but not total cesarean delivery) and preterm delivery, but not with a reduced risk of outcomes including preeclampsia, emergency cesarean delivery, induction of labor, or maternal birth trauma.

The task force also reviewed seven studies of harms associated with screening for gestational diabetes, including three on psychosocial harms, three on hospital experiences, and one of the odds of cesarean delivery after a diagnosis of gestational diabetes. No increase in anxiety or depression occurred following a positive diagnosis or false-positive test result, but data suggested that a gestational diabetes diagnosis may be associated with higher rates of cesarean delivery.

A total of 13 trials evaluated the harms associated with treatment of gestational diabetes, and found no association between treatment and increased risk of several outcomes including severe maternal hypoglycemia, low birth weight, and small for gestational age, and no effect was noted on the number of cesarean deliveries.

Evidence gaps that require additional research include randomized, controlled trials on the effects of gestational diabetes screening on health outcomes, as well as benefits versus harms of screening for pregnant individuals prior to 24 weeks, and studies on the effects of screening in subpopulations of race/ethnicity, age, and socioeconomic factors, according to the task force. Additional research also is needed in areas of maternal health outcomes, long-term outcomes, and the effect on outcomes of one-step versus two-step screening, the USPSTF said.

However, “screening for and detecting gestational diabetes provides a potential opportunity to control blood glucose levels (through lifestyle changes, pharmacological interventions, or both) and reduce the risk of macrosomia and LGA [large for gestational age] infants,” the task force wrote. “In turn, this can prevent associated complications such as primary cesarean delivery, shoulder dystocia, and [neonatal] ICU admissions.”
 

Support screening with counseling on risk reduction

The USPSTF recommendation is important at this time because “the prevalence of gestational diabetes is increasing secondary to rising rates of obesity,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

“In 2014, based on a systematic review of literature, the USPSTF recommended screening all asymptomatic pregnant women for gestational diabetes mellitus [GDM] starting at 24 weeks’ gestation. The recommended gestational age for screening coincides with increasing insulin resistance during pregnancy with advancing gestational age,” Dr. Krishna said.

“An updated systematic review by the USPSTF concluded that existing literature continues to affirm current recommendations of universal screening for GDM at 24 weeks gestation or later. There continues, however, to be no consensus on the optimal approach to screening,” she noted.

“Screening can be performed as a two-step or one-step approach,” said Dr. Krishna. “The two-step approach is commonly used in the United States, and all pregnant women are first screened with a 50-gram oral glucose solution followed by a diagnostic test if they have a positive initial screening.

“Women with risk factors for diabetes, such as prior GDM, obesity, strong family history of diabetes, or history of fetal macrosomia, should be screened early in pregnancy for GDM and have the GDM screen repeated at 24 weeks’ gestation or later if normal in early pregnancy,” Dr. Krishna said. “Pregnant women should be counseled on the importance of diet and exercise and appropriate weight gain in pregnancy to reduce the risk of GDM. Overall, timely diagnosis of gestational diabetes is crucial to improving maternal and fetal pregnancy outcomes.”

The full recommendation statement is also available on the USPSTF website. The research was supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Krishna had no disclosures, but serves on the editorial advisory board of Ob.Gyn News.

Asymptomatic pregnant women with no previous diagnosis of type 1 or 2 diabetes should be screened for gestational diabetes at 24 weeks’ gestation or later, according to an updated recommendation from the U.S. Preventive Services Task Force.

Pregnant individuals who develop gestational diabetes are at increased risk for complications including preeclampsia, fetal macrosomia, and neonatal hypoglycemia, as well as negative long-term outcomes for themselves and their children, wrote lead author Karina W. Davidson, PhD, of Feinstein Institute for Medical Research, Manhasset, N.Y., and colleagues. The statement was published online in JAMA.

The B recommendation and I statement reflect “moderate certainty” that current evidence supports the recommendation in terms of harms versus benefits, and is consistent with the 2014 USPSTF recommendation.

The statement calls for a one-time screening using a glucose tolerance test at or after 24 weeks’ gestation. Although most screening in the United States takes place prior to 28 weeks’ gestation, it can be performed later in patients who begin prenatal care after 28 weeks’ gestation, according to the statement. Data on the harms and benefits of gestational diabetes screening prior to 24 weeks’ gestation are limited, the authors noted. Gestational diabetes was defined as diabetes that develops during pregnancy that is not clearly overt diabetes.

To update the 2014 recommendation, the USPSTF commissioned a systematic review. In 45 prospective studies on the accuracy of gestational diabetes screening, several tests, included oral glucose challenge test, oral glucose tolerance test, and fasting plasma glucose using either a one- or two-step approach were accurate detectors of gestational diabetes; therefore, the USPSTF does not recommend a specific test.

In 13 trials on the impact of treating gestational diabetes on intermediate and health outcomes, treatment was associated with a reduced risk of outcomes, including primary cesarean delivery (but not total cesarean delivery) and preterm delivery, but not with a reduced risk of outcomes including preeclampsia, emergency cesarean delivery, induction of labor, or maternal birth trauma.

The task force also reviewed seven studies of harms associated with screening for gestational diabetes, including three on psychosocial harms, three on hospital experiences, and one of the odds of cesarean delivery after a diagnosis of gestational diabetes. No increase in anxiety or depression occurred following a positive diagnosis or false-positive test result, but data suggested that a gestational diabetes diagnosis may be associated with higher rates of cesarean delivery.

A total of 13 trials evaluated the harms associated with treatment of gestational diabetes, and found no association between treatment and increased risk of several outcomes including severe maternal hypoglycemia, low birth weight, and small for gestational age, and no effect was noted on the number of cesarean deliveries.

Evidence gaps that require additional research include randomized, controlled trials on the effects of gestational diabetes screening on health outcomes, as well as benefits versus harms of screening for pregnant individuals prior to 24 weeks, and studies on the effects of screening in subpopulations of race/ethnicity, age, and socioeconomic factors, according to the task force. Additional research also is needed in areas of maternal health outcomes, long-term outcomes, and the effect on outcomes of one-step versus two-step screening, the USPSTF said.

However, “screening for and detecting gestational diabetes provides a potential opportunity to control blood glucose levels (through lifestyle changes, pharmacological interventions, or both) and reduce the risk of macrosomia and LGA [large for gestational age] infants,” the task force wrote. “In turn, this can prevent associated complications such as primary cesarean delivery, shoulder dystocia, and [neonatal] ICU admissions.”
 

Support screening with counseling on risk reduction

The USPSTF recommendation is important at this time because “the prevalence of gestational diabetes is increasing secondary to rising rates of obesity,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

“In 2014, based on a systematic review of literature, the USPSTF recommended screening all asymptomatic pregnant women for gestational diabetes mellitus [GDM] starting at 24 weeks’ gestation. The recommended gestational age for screening coincides with increasing insulin resistance during pregnancy with advancing gestational age,” Dr. Krishna said.

“An updated systematic review by the USPSTF concluded that existing literature continues to affirm current recommendations of universal screening for GDM at 24 weeks gestation or later. There continues, however, to be no consensus on the optimal approach to screening,” she noted.

“Screening can be performed as a two-step or one-step approach,” said Dr. Krishna. “The two-step approach is commonly used in the United States, and all pregnant women are first screened with a 50-gram oral glucose solution followed by a diagnostic test if they have a positive initial screening.

“Women with risk factors for diabetes, such as prior GDM, obesity, strong family history of diabetes, or history of fetal macrosomia, should be screened early in pregnancy for GDM and have the GDM screen repeated at 24 weeks’ gestation or later if normal in early pregnancy,” Dr. Krishna said. “Pregnant women should be counseled on the importance of diet and exercise and appropriate weight gain in pregnancy to reduce the risk of GDM. Overall, timely diagnosis of gestational diabetes is crucial to improving maternal and fetal pregnancy outcomes.”

The full recommendation statement is also available on the USPSTF website. The research was supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Krishna had no disclosures, but serves on the editorial advisory board of Ob.Gyn News.

Asymptomatic pregnant women with no previous diagnosis of type 1 or 2 diabetes should be screened for gestational diabetes at 24 weeks’ gestation or later, according to an updated recommendation from the U.S. Preventive Services Task Force.

Pregnant individuals who develop gestational diabetes are at increased risk for complications including preeclampsia, fetal macrosomia, and neonatal hypoglycemia, as well as negative long-term outcomes for themselves and their children, wrote lead author Karina W. Davidson, PhD, of Feinstein Institute for Medical Research, Manhasset, N.Y., and colleagues. The statement was published online in JAMA.

The B recommendation and I statement reflect “moderate certainty” that current evidence supports the recommendation in terms of harms versus benefits, and is consistent with the 2014 USPSTF recommendation.

The statement calls for a one-time screening using a glucose tolerance test at or after 24 weeks’ gestation. Although most screening in the United States takes place prior to 28 weeks’ gestation, it can be performed later in patients who begin prenatal care after 28 weeks’ gestation, according to the statement. Data on the harms and benefits of gestational diabetes screening prior to 24 weeks’ gestation are limited, the authors noted. Gestational diabetes was defined as diabetes that develops during pregnancy that is not clearly overt diabetes.

To update the 2014 recommendation, the USPSTF commissioned a systematic review. In 45 prospective studies on the accuracy of gestational diabetes screening, several tests, included oral glucose challenge test, oral glucose tolerance test, and fasting plasma glucose using either a one- or two-step approach were accurate detectors of gestational diabetes; therefore, the USPSTF does not recommend a specific test.

In 13 trials on the impact of treating gestational diabetes on intermediate and health outcomes, treatment was associated with a reduced risk of outcomes, including primary cesarean delivery (but not total cesarean delivery) and preterm delivery, but not with a reduced risk of outcomes including preeclampsia, emergency cesarean delivery, induction of labor, or maternal birth trauma.

The task force also reviewed seven studies of harms associated with screening for gestational diabetes, including three on psychosocial harms, three on hospital experiences, and one of the odds of cesarean delivery after a diagnosis of gestational diabetes. No increase in anxiety or depression occurred following a positive diagnosis or false-positive test result, but data suggested that a gestational diabetes diagnosis may be associated with higher rates of cesarean delivery.

A total of 13 trials evaluated the harms associated with treatment of gestational diabetes, and found no association between treatment and increased risk of several outcomes including severe maternal hypoglycemia, low birth weight, and small for gestational age, and no effect was noted on the number of cesarean deliveries.

Evidence gaps that require additional research include randomized, controlled trials on the effects of gestational diabetes screening on health outcomes, as well as benefits versus harms of screening for pregnant individuals prior to 24 weeks, and studies on the effects of screening in subpopulations of race/ethnicity, age, and socioeconomic factors, according to the task force. Additional research also is needed in areas of maternal health outcomes, long-term outcomes, and the effect on outcomes of one-step versus two-step screening, the USPSTF said.

However, “screening for and detecting gestational diabetes provides a potential opportunity to control blood glucose levels (through lifestyle changes, pharmacological interventions, or both) and reduce the risk of macrosomia and LGA [large for gestational age] infants,” the task force wrote. “In turn, this can prevent associated complications such as primary cesarean delivery, shoulder dystocia, and [neonatal] ICU admissions.”
 

Support screening with counseling on risk reduction

The USPSTF recommendation is important at this time because “the prevalence of gestational diabetes is increasing secondary to rising rates of obesity,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

“In 2014, based on a systematic review of literature, the USPSTF recommended screening all asymptomatic pregnant women for gestational diabetes mellitus [GDM] starting at 24 weeks’ gestation. The recommended gestational age for screening coincides with increasing insulin resistance during pregnancy with advancing gestational age,” Dr. Krishna said.

“An updated systematic review by the USPSTF concluded that existing literature continues to affirm current recommendations of universal screening for GDM at 24 weeks gestation or later. There continues, however, to be no consensus on the optimal approach to screening,” she noted.

“Screening can be performed as a two-step or one-step approach,” said Dr. Krishna. “The two-step approach is commonly used in the United States, and all pregnant women are first screened with a 50-gram oral glucose solution followed by a diagnostic test if they have a positive initial screening.

“Women with risk factors for diabetes, such as prior GDM, obesity, strong family history of diabetes, or history of fetal macrosomia, should be screened early in pregnancy for GDM and have the GDM screen repeated at 24 weeks’ gestation or later if normal in early pregnancy,” Dr. Krishna said. “Pregnant women should be counseled on the importance of diet and exercise and appropriate weight gain in pregnancy to reduce the risk of GDM. Overall, timely diagnosis of gestational diabetes is crucial to improving maternal and fetal pregnancy outcomes.”

The full recommendation statement is also available on the USPSTF website. The research was supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Krishna had no disclosures, but serves on the editorial advisory board of Ob.Gyn News.

Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.