Diabetes Hub

Programs designed to promote diet and physical activity, specifically geared toward individuals at high risk for developing type 2 diabetes, can be effective at reducing the number of new-onset diabetes cases, according to a recommendation from the Community Preventive Services Task Force.

The recommendation was derived from a review of 53 studies examining 66 programs already in place across the nation, which presented a consensus that promoting dietary changes and increased physical activity in either a clinical or community engagement setting can significantly decrease the risk of at-risk individuals to develop type 2 diabetes (Ann. Intern. Med. 2015 July 13 [doi:10.7326/M15-1029]).

These programs vary in several ways – length, method of delivery, and individual versus group-based activities – but all share the common goal of education and awareness of diabetes and measures to prevent it.

© imtmphoto/Thinkstock

“Programs commonly include a weight-loss goal, individual or group sessions (or both) about diet and exercise, meetings with a trained diet or exercise counselor (or both), and individually tailored diet or exercise plans (or both),” wrote Dr. Nicolaas P. Pronk and Dr. Patrick L. Remington. “Higher-intensity programs lead to greater weight loss and reduction in new-onset diabetes.”

From a search of MEDLINE, the Cochrane Central Register of Controlled Trials, CAB Abstracts, Global Health, and Ovid HealthSTAR from 1991 through 2015, investigators with the Community Preventive Services Task Force included randomized, controlled trials and prospective nonrandomized comparative studies of at least 30 participants. All programs examined by the included studies ran from 3 months to 6 years in length, with all but 5 programs being longer than 6 months. Programs mostly used in-person exercises, either individually or in a group setting, focusing on diet improvement or exercise.

Programs were typically led by nutritionists or physical trainers, but several were also led by physicians, psychologists, nurses, or a “trained layperson.” The recommendations highlight that while some programs had participants outline specific goals and all programs varied in the intensity and style of their counseling, they all led to either reduced risk of diabetes, weight loss, or both.

“In 17 studies that reported blood pressure outcomes and 14 that reported lipid outcomes, programs reduced systolic and diastolic blood pressures and improved lipid levels, including total, low-density lipoprotein, and high-density lipoprotein cholesterol levels and triglyceride levels,” the recommendations state, adding that no long-term ramifications were reported relating to any of the programs.

Economic review of 28 programs indicated that median program cost per participant was $653, although this cost was substantially lower for programs in either community or primary care-based settings (median cost of $424) and group-based programs (median cost of $417). While these costs can be prohibitively high for many Americans, the recommendations advise that many employers list health programs as a covered benefit, and urges private and public health insurers to join in covering participation costs. Most programs also offer free information online.

The Community Preventive Services Task Force is an independent, unpaid, nonfederal body. Dr. Pronk and Dr. Remington did not report any relevant financial disclosures.

What is the Community Preventive Services Task Force?

The U.S. Community Preventive Services Task Force was created in 1996 by the U.S. Department of Health and Human Services with the goal of making recommendations and identifying evidence gaps in existing knowledge and research to “help inform the decision making of federal, state, and local health departments, other government agencies, communities, healthcare providers, employers, schools and research organizations.”

These findings are released as The Community Guide, which collects information on studies of relevant public health topics, assesses the strengths and weaknesses of these studies and their findings, and summarizes the evidence in a way that presents whether or not intervention is necessary, how to make an intervention the most effective it can be, what costs would be associated with such an intervention, and what gaps in our existing knowledge or research exist that should be rectified.

As of passage of the Patient Protection and Affordable Care Act in 2010, the task force’s findings are collected in an annual report presented to Congress, which has mandated the Centers for Disease Control and Prevention to support the work of the task force even though the task force is considered an independent, nonfederal, unpaid body. However, according to a disclaimer from the task force’s most recent clinical guideline, “recommendations made by the Task Force are independent of the U.S. government and should not be construed as an official position of the Centers for Disease Control and Prevention or the U.S. Department of Health and Human Services.

The 14 current members of the task force come from across the country, and from both the private and public spheres. The task force is chaired by Dr. Jonathan E. Fielding, director of and a health officer in the Los Angeles County Department of Health.

[email protected]

Programs designed to promote diet and physical activity, specifically geared toward individuals at high risk for developing type 2 diabetes, can be effective at reducing the number of new-onset diabetes cases, according to a recommendation from the Community Preventive Services Task Force.

The recommendation was derived from a review of 53 studies examining 66 programs already in place across the nation, which presented a consensus that promoting dietary changes and increased physical activity in either a clinical or community engagement setting can significantly decrease the risk of at-risk individuals to develop type 2 diabetes (Ann. Intern. Med. 2015 July 13 [doi:10.7326/M15-1029]).

These programs vary in several ways – length, method of delivery, and individual versus group-based activities – but all share the common goal of education and awareness of diabetes and measures to prevent it.

© imtmphoto/Thinkstock

“Programs commonly include a weight-loss goal, individual or group sessions (or both) about diet and exercise, meetings with a trained diet or exercise counselor (or both), and individually tailored diet or exercise plans (or both),” wrote Dr. Nicolaas P. Pronk and Dr. Patrick L. Remington. “Higher-intensity programs lead to greater weight loss and reduction in new-onset diabetes.”

From a search of MEDLINE, the Cochrane Central Register of Controlled Trials, CAB Abstracts, Global Health, and Ovid HealthSTAR from 1991 through 2015, investigators with the Community Preventive Services Task Force included randomized, controlled trials and prospective nonrandomized comparative studies of at least 30 participants. All programs examined by the included studies ran from 3 months to 6 years in length, with all but 5 programs being longer than 6 months. Programs mostly used in-person exercises, either individually or in a group setting, focusing on diet improvement or exercise.

Programs were typically led by nutritionists or physical trainers, but several were also led by physicians, psychologists, nurses, or a “trained layperson.” The recommendations highlight that while some programs had participants outline specific goals and all programs varied in the intensity and style of their counseling, they all led to either reduced risk of diabetes, weight loss, or both.

“In 17 studies that reported blood pressure outcomes and 14 that reported lipid outcomes, programs reduced systolic and diastolic blood pressures and improved lipid levels, including total, low-density lipoprotein, and high-density lipoprotein cholesterol levels and triglyceride levels,” the recommendations state, adding that no long-term ramifications were reported relating to any of the programs.

Economic review of 28 programs indicated that median program cost per participant was $653, although this cost was substantially lower for programs in either community or primary care-based settings (median cost of $424) and group-based programs (median cost of $417). While these costs can be prohibitively high for many Americans, the recommendations advise that many employers list health programs as a covered benefit, and urges private and public health insurers to join in covering participation costs. Most programs also offer free information online.

The Community Preventive Services Task Force is an independent, unpaid, nonfederal body. Dr. Pronk and Dr. Remington did not report any relevant financial disclosures.

What is the Community Preventive Services Task Force?

The U.S. Community Preventive Services Task Force was created in 1996 by the U.S. Department of Health and Human Services with the goal of making recommendations and identifying evidence gaps in existing knowledge and research to “help inform the decision making of federal, state, and local health departments, other government agencies, communities, healthcare providers, employers, schools and research organizations.”

These findings are released as The Community Guide, which collects information on studies of relevant public health topics, assesses the strengths and weaknesses of these studies and their findings, and summarizes the evidence in a way that presents whether or not intervention is necessary, how to make an intervention the most effective it can be, what costs would be associated with such an intervention, and what gaps in our existing knowledge or research exist that should be rectified.

As of passage of the Patient Protection and Affordable Care Act in 2010, the task force’s findings are collected in an annual report presented to Congress, which has mandated the Centers for Disease Control and Prevention to support the work of the task force even though the task force is considered an independent, nonfederal, unpaid body. However, according to a disclaimer from the task force’s most recent clinical guideline, “recommendations made by the Task Force are independent of the U.S. government and should not be construed as an official position of the Centers for Disease Control and Prevention or the U.S. Department of Health and Human Services.

The 14 current members of the task force come from across the country, and from both the private and public spheres. The task force is chaired by Dr. Jonathan E. Fielding, director of and a health officer in the Los Angeles County Department of Health.

[email protected]

Programs designed to promote diet and physical activity, specifically geared toward individuals at high risk for developing type 2 diabetes, can be effective at reducing the number of new-onset diabetes cases, according to a recommendation from the Community Preventive Services Task Force.

The recommendation was derived from a review of 53 studies examining 66 programs already in place across the nation, which presented a consensus that promoting dietary changes and increased physical activity in either a clinical or community engagement setting can significantly decrease the risk of at-risk individuals to develop type 2 diabetes (Ann. Intern. Med. 2015 July 13 [doi:10.7326/M15-1029]).

These programs vary in several ways – length, method of delivery, and individual versus group-based activities – but all share the common goal of education and awareness of diabetes and measures to prevent it.

© imtmphoto/Thinkstock

“Programs commonly include a weight-loss goal, individual or group sessions (or both) about diet and exercise, meetings with a trained diet or exercise counselor (or both), and individually tailored diet or exercise plans (or both),” wrote Dr. Nicolaas P. Pronk and Dr. Patrick L. Remington. “Higher-intensity programs lead to greater weight loss and reduction in new-onset diabetes.”

From a search of MEDLINE, the Cochrane Central Register of Controlled Trials, CAB Abstracts, Global Health, and Ovid HealthSTAR from 1991 through 2015, investigators with the Community Preventive Services Task Force included randomized, controlled trials and prospective nonrandomized comparative studies of at least 30 participants. All programs examined by the included studies ran from 3 months to 6 years in length, with all but 5 programs being longer than 6 months. Programs mostly used in-person exercises, either individually or in a group setting, focusing on diet improvement or exercise.

Programs were typically led by nutritionists or physical trainers, but several were also led by physicians, psychologists, nurses, or a “trained layperson.” The recommendations highlight that while some programs had participants outline specific goals and all programs varied in the intensity and style of their counseling, they all led to either reduced risk of diabetes, weight loss, or both.

“In 17 studies that reported blood pressure outcomes and 14 that reported lipid outcomes, programs reduced systolic and diastolic blood pressures and improved lipid levels, including total, low-density lipoprotein, and high-density lipoprotein cholesterol levels and triglyceride levels,” the recommendations state, adding that no long-term ramifications were reported relating to any of the programs.

Economic review of 28 programs indicated that median program cost per participant was $653, although this cost was substantially lower for programs in either community or primary care-based settings (median cost of $424) and group-based programs (median cost of $417). While these costs can be prohibitively high for many Americans, the recommendations advise that many employers list health programs as a covered benefit, and urges private and public health insurers to join in covering participation costs. Most programs also offer free information online.

The Community Preventive Services Task Force is an independent, unpaid, nonfederal body. Dr. Pronk and Dr. Remington did not report any relevant financial disclosures.

What is the Community Preventive Services Task Force?

The U.S. Community Preventive Services Task Force was created in 1996 by the U.S. Department of Health and Human Services with the goal of making recommendations and identifying evidence gaps in existing knowledge and research to “help inform the decision making of federal, state, and local health departments, other government agencies, communities, healthcare providers, employers, schools and research organizations.”

These findings are released as The Community Guide, which collects information on studies of relevant public health topics, assesses the strengths and weaknesses of these studies and their findings, and summarizes the evidence in a way that presents whether or not intervention is necessary, how to make an intervention the most effective it can be, what costs would be associated with such an intervention, and what gaps in our existing knowledge or research exist that should be rectified.

As of passage of the Patient Protection and Affordable Care Act in 2010, the task force’s findings are collected in an annual report presented to Congress, which has mandated the Centers for Disease Control and Prevention to support the work of the task force even though the task force is considered an independent, nonfederal, unpaid body. However, according to a disclaimer from the task force’s most recent clinical guideline, “recommendations made by the Task Force are independent of the U.S. government and should not be construed as an official position of the Centers for Disease Control and Prevention or the U.S. Department of Health and Human Services.

The 14 current members of the task force come from across the country, and from both the private and public spheres. The task force is chaired by Dr. Jonathan E. Fielding, director of and a health officer in the Los Angeles County Department of Health.

[email protected]

U.S. children’s and teens’ average blood pressure levels have dropped over the past decade, with a commensurate drop in elevated and high blood pressure among those under 18, according to a new study.

“Inconsistent with previous four studies, results of the current study may indicate promising effects of public health improvement on healthy lifestyles and dietary behaviors on blood pressure control in children and adolescents,” reported Dr. Bo Xi of Shandong University, Jinan, China, and associates. “Reduction of daily intakes of energy, carbohydrate, total fat, and total saturated fatty acids among U.S. children and adolescents may help explain the decrease in mean blood pressure levels and prevalence of elevated blood pressure” (Am. J. Hypertens. 2015 July 8 [doi:10.1093/ajh/hpv091]).

The researchers grouped data from the 14,270 children, aged 8-17 years, in the seven National Health and Nutrition Examination Surveys from 1999 to 2012 into three time periods: 1999-2002, 2003-2008, and 2009-2012. They defined high blood pressure as a systolic and/or diastolic blood pressure at the 95th percentile or higher for a child’s sex, age, and height. Elevated blood pressure fell between the 90th and 95th percentile or at least 120/80 mm Hg.

From 1999-2002 to 2009-2012, both average systolic and diastolic blood pressure dropped overall, 0.7 and 4.2 mm Hg, respectively. Diastolic blood pressure dropped for both males and females, for those in the lower (8-12) and higher (13-17) age groups, and across all race/ethnicity groups. Only girls, whites, and those aged 8-12 years saw overall drops in average systolic blood pressure.

From 2009 to 2012, nearly one in 10 children and teens (9.6%) had elevated blood pressure, and 1.6% had high blood pressure. The prevalence of elevated blood pressure and high blood pressure had dropped 2.8 percentage points and 1.3 percentage points, respectively, since 1999-2002. However, teens remained more likely to have elevated blood pressure (odds ratio, 2.62), compared with children, and blacks had higher odds than did whites (OR = 1.39). Girls had half the odds that boys had (OR = 0.5). The trends were similar for high blood pressure.

The total daily calories, carbohydrates, fat, and saturated fatty acids intake among children and teens also decreased from 1999-2002 to 2009-2012, while polyunsaturated fatty acids and dietary fiber intake increased. Sodium, potassium, protein, cholesterol, and caffeine intake did not change during this time, independent of adjustments for body mass index–Z scores. The researchers also found a sodium intake of more than 3,450 mg/d was linked to a higher systolic blood pressure and prevalence of elevated blood pressure, compared with an intake remaining at or below 2,300 mg/d, the recommended daily intake level.

The National Institutes of Health, the Scientific Research Organization Construction Project of Shandong University, and the Research Fund for the Doctoral Program of Higher Education of China supported the study. The authors reported no conflicts of interest.

U.S. children’s and teens’ average blood pressure levels have dropped over the past decade, with a commensurate drop in elevated and high blood pressure among those under 18, according to a new study.

“Inconsistent with previous four studies, results of the current study may indicate promising effects of public health improvement on healthy lifestyles and dietary behaviors on blood pressure control in children and adolescents,” reported Dr. Bo Xi of Shandong University, Jinan, China, and associates. “Reduction of daily intakes of energy, carbohydrate, total fat, and total saturated fatty acids among U.S. children and adolescents may help explain the decrease in mean blood pressure levels and prevalence of elevated blood pressure” (Am. J. Hypertens. 2015 July 8 [doi:10.1093/ajh/hpv091]).

The researchers grouped data from the 14,270 children, aged 8-17 years, in the seven National Health and Nutrition Examination Surveys from 1999 to 2012 into three time periods: 1999-2002, 2003-2008, and 2009-2012. They defined high blood pressure as a systolic and/or diastolic blood pressure at the 95th percentile or higher for a child’s sex, age, and height. Elevated blood pressure fell between the 90th and 95th percentile or at least 120/80 mm Hg.

From 1999-2002 to 2009-2012, both average systolic and diastolic blood pressure dropped overall, 0.7 and 4.2 mm Hg, respectively. Diastolic blood pressure dropped for both males and females, for those in the lower (8-12) and higher (13-17) age groups, and across all race/ethnicity groups. Only girls, whites, and those aged 8-12 years saw overall drops in average systolic blood pressure.

From 2009 to 2012, nearly one in 10 children and teens (9.6%) had elevated blood pressure, and 1.6% had high blood pressure. The prevalence of elevated blood pressure and high blood pressure had dropped 2.8 percentage points and 1.3 percentage points, respectively, since 1999-2002. However, teens remained more likely to have elevated blood pressure (odds ratio, 2.62), compared with children, and blacks had higher odds than did whites (OR = 1.39). Girls had half the odds that boys had (OR = 0.5). The trends were similar for high blood pressure.

The total daily calories, carbohydrates, fat, and saturated fatty acids intake among children and teens also decreased from 1999-2002 to 2009-2012, while polyunsaturated fatty acids and dietary fiber intake increased. Sodium, potassium, protein, cholesterol, and caffeine intake did not change during this time, independent of adjustments for body mass index–Z scores. The researchers also found a sodium intake of more than 3,450 mg/d was linked to a higher systolic blood pressure and prevalence of elevated blood pressure, compared with an intake remaining at or below 2,300 mg/d, the recommended daily intake level.

The National Institutes of Health, the Scientific Research Organization Construction Project of Shandong University, and the Research Fund for the Doctoral Program of Higher Education of China supported the study. The authors reported no conflicts of interest.

U.S. children’s and teens’ average blood pressure levels have dropped over the past decade, with a commensurate drop in elevated and high blood pressure among those under 18, according to a new study.

“Inconsistent with previous four studies, results of the current study may indicate promising effects of public health improvement on healthy lifestyles and dietary behaviors on blood pressure control in children and adolescents,” reported Dr. Bo Xi of Shandong University, Jinan, China, and associates. “Reduction of daily intakes of energy, carbohydrate, total fat, and total saturated fatty acids among U.S. children and adolescents may help explain the decrease in mean blood pressure levels and prevalence of elevated blood pressure” (Am. J. Hypertens. 2015 July 8 [doi:10.1093/ajh/hpv091]).

The researchers grouped data from the 14,270 children, aged 8-17 years, in the seven National Health and Nutrition Examination Surveys from 1999 to 2012 into three time periods: 1999-2002, 2003-2008, and 2009-2012. They defined high blood pressure as a systolic and/or diastolic blood pressure at the 95th percentile or higher for a child’s sex, age, and height. Elevated blood pressure fell between the 90th and 95th percentile or at least 120/80 mm Hg.

From 1999-2002 to 2009-2012, both average systolic and diastolic blood pressure dropped overall, 0.7 and 4.2 mm Hg, respectively. Diastolic blood pressure dropped for both males and females, for those in the lower (8-12) and higher (13-17) age groups, and across all race/ethnicity groups. Only girls, whites, and those aged 8-12 years saw overall drops in average systolic blood pressure.

From 2009 to 2012, nearly one in 10 children and teens (9.6%) had elevated blood pressure, and 1.6% had high blood pressure. The prevalence of elevated blood pressure and high blood pressure had dropped 2.8 percentage points and 1.3 percentage points, respectively, since 1999-2002. However, teens remained more likely to have elevated blood pressure (odds ratio, 2.62), compared with children, and blacks had higher odds than did whites (OR = 1.39). Girls had half the odds that boys had (OR = 0.5). The trends were similar for high blood pressure.

The total daily calories, carbohydrates, fat, and saturated fatty acids intake among children and teens also decreased from 1999-2002 to 2009-2012, while polyunsaturated fatty acids and dietary fiber intake increased. Sodium, potassium, protein, cholesterol, and caffeine intake did not change during this time, independent of adjustments for body mass index–Z scores. The researchers also found a sodium intake of more than 3,450 mg/d was linked to a higher systolic blood pressure and prevalence of elevated blood pressure, compared with an intake remaining at or below 2,300 mg/d, the recommended daily intake level.

The National Institutes of Health, the Scientific Research Organization Construction Project of Shandong University, and the Research Fund for the Doctoral Program of Higher Education of China supported the study. The authors reported no conflicts of interest.

BOSTON – Liraglutide in combination with metformin reduced epicardial adipose tissue by nearly half within 6 months of treatment in people with type 2 diabetes, an effect independent of either body weight loss or glycemic control, according to a new study.

Epicardial adipose tissue (EAT) is the fat depot around the heart. While EAT has many cardioprotective properties, increased or excess EAT – seen more frequently in people with type 2 diabetes – has been linked to coronary artery disease, metabolic syndrome, diabetes, insulin resistance, and liver disease, according to a review by Gianluca Iacobellis, M.D., Ph.D., professor of clinical medicine in the division of endocrinology, diabetes and metabolism at the University of Miami (Nat. Rev. Endocrinol. 2015;11: 363-71).

More than a decade ago, Dr. Iacobellis proposed and validated ultrasound measurement of EAT thickness as marker of visceral fat and a therapeutic target (J. Clin. Endocrinol. Metab. 2003;88: 5163-8).

At the annual scientific sessions of the American Diabetes Association, Dr. Iacobellis presented preliminary findings from a case-control study in 35 patients with type 2 diabetes with body mass indexes greater than 27 kg/m² and hemoglobin A_1c levels no greater than 8% on metformin monotherapy.

Patients were randomized to remain on metformin or metformin plus the glucagon-like peptide-1 (GLP-1) analogue liraglutide subcutaneously up to 1.8 mg once daily for 6 months. EAT thickness was measured by ultrasound at baseline, 3 months, and 6 months, along with HbA_1c and BMI measures. In the liraglutide group (20 patients), EAT decreased significantly from 10.2 mm to 6.9 mm and 5.8 mm (P < 0.001) after 3 months and 6 months, respectively, for a 42% reduction at 6 months. The metformin-only group (15 patients) saw no reduction in EAT.

The EAT reduction seen in the intervention group was much greater than, and independent of, reductions in body weight or HbA_1c. Average BMI fell from 33 kg/m² at baseline to 31.8 kg/m² and 31.7 kg/m² at 3 months and 6 months, respectively, while HbA_1c declined 18% among patients on liraglutide.

The findings have important clinical and research implications, Dr. Iacobellis said in an interview. “Emerging evidence is pointing out that EAT as measured with reliable, safe, and cheap ultrasound can be a therapeutic target for medications directly or indirectly targeting the adipose tissue,” he said. And EAT can be measured in clinical settings, he added.

Moreover, there is a strong likelihood that further studies will show cardiovascular benefit associated with reductions in EAT, Dr. Iacobellis predicted.

“There is a direct cross-talk between the cardiac fat and the heart,” he said. “If you target the fat, if you’re able to modulate or to reduce the adipose tissue of the heart, you can directly modulate the myocardium and improve cardiovascular performance.”

Dr. Iacobellis’ study on liraglutide is ongoing, and the investigators are examining the effects of other classes of drugs, including the sodium-glucose cotransporter-2 (SLGT-2) inhibitors, on EAT in people with type 2 diabetes. Dr. Iacobellis said he did not know whether to consider the EAT reduction a likely class effect of GLP-1 analogue medications. It is biologically plausible, he added, because human adipose tissues express GLP-1 receptors.

Other studies are showing that exenatide may have some beneficial cardiovascular effect in patients with coronary artery disease, he said. “However, liraglutide seems to be the most effective in targeting the adipose tissue. There may be a class effect, but one drug could have a more prominent effect compared to others.”

It is possible that liraglutide’s metabolic and weight-loss benefits are in some way mediated by its effect on EAT and other visceral fat depots, Dr. Iacobellis observed, although further research will be needed to show that.

“We know that people lose weight on liraglutide, and we know they have an improvement in glucose control. But what we don’t know is whether the metabolic improvement is actually driven by an effect of the medication on the organ-specific fat depot,” he said.

Novo Nordisk and the University of Miami sponsored the study. Neither Dr. Iacobellis nor his coauthors disclosed conflicts of interest.

BOSTON – Liraglutide in combination with metformin reduced epicardial adipose tissue by nearly half within 6 months of treatment in people with type 2 diabetes, an effect independent of either body weight loss or glycemic control, according to a new study.

Epicardial adipose tissue (EAT) is the fat depot around the heart. While EAT has many cardioprotective properties, increased or excess EAT – seen more frequently in people with type 2 diabetes – has been linked to coronary artery disease, metabolic syndrome, diabetes, insulin resistance, and liver disease, according to a review by Gianluca Iacobellis, M.D., Ph.D., professor of clinical medicine in the division of endocrinology, diabetes and metabolism at the University of Miami (Nat. Rev. Endocrinol. 2015;11: 363-71).

More than a decade ago, Dr. Iacobellis proposed and validated ultrasound measurement of EAT thickness as marker of visceral fat and a therapeutic target (J. Clin. Endocrinol. Metab. 2003;88: 5163-8).

At the annual scientific sessions of the American Diabetes Association, Dr. Iacobellis presented preliminary findings from a case-control study in 35 patients with type 2 diabetes with body mass indexes greater than 27 kg/m² and hemoglobin A_1c levels no greater than 8% on metformin monotherapy.

Patients were randomized to remain on metformin or metformin plus the glucagon-like peptide-1 (GLP-1) analogue liraglutide subcutaneously up to 1.8 mg once daily for 6 months. EAT thickness was measured by ultrasound at baseline, 3 months, and 6 months, along with HbA_1c and BMI measures. In the liraglutide group (20 patients), EAT decreased significantly from 10.2 mm to 6.9 mm and 5.8 mm (P < 0.001) after 3 months and 6 months, respectively, for a 42% reduction at 6 months. The metformin-only group (15 patients) saw no reduction in EAT.

The EAT reduction seen in the intervention group was much greater than, and independent of, reductions in body weight or HbA_1c. Average BMI fell from 33 kg/m² at baseline to 31.8 kg/m² and 31.7 kg/m² at 3 months and 6 months, respectively, while HbA_1c declined 18% among patients on liraglutide.

The findings have important clinical and research implications, Dr. Iacobellis said in an interview. “Emerging evidence is pointing out that EAT as measured with reliable, safe, and cheap ultrasound can be a therapeutic target for medications directly or indirectly targeting the adipose tissue,” he said. And EAT can be measured in clinical settings, he added.

Moreover, there is a strong likelihood that further studies will show cardiovascular benefit associated with reductions in EAT, Dr. Iacobellis predicted.

“There is a direct cross-talk between the cardiac fat and the heart,” he said. “If you target the fat, if you’re able to modulate or to reduce the adipose tissue of the heart, you can directly modulate the myocardium and improve cardiovascular performance.”

Dr. Iacobellis’ study on liraglutide is ongoing, and the investigators are examining the effects of other classes of drugs, including the sodium-glucose cotransporter-2 (SLGT-2) inhibitors, on EAT in people with type 2 diabetes. Dr. Iacobellis said he did not know whether to consider the EAT reduction a likely class effect of GLP-1 analogue medications. It is biologically plausible, he added, because human adipose tissues express GLP-1 receptors.

Other studies are showing that exenatide may have some beneficial cardiovascular effect in patients with coronary artery disease, he said. “However, liraglutide seems to be the most effective in targeting the adipose tissue. There may be a class effect, but one drug could have a more prominent effect compared to others.”

It is possible that liraglutide’s metabolic and weight-loss benefits are in some way mediated by its effect on EAT and other visceral fat depots, Dr. Iacobellis observed, although further research will be needed to show that.

“We know that people lose weight on liraglutide, and we know they have an improvement in glucose control. But what we don’t know is whether the metabolic improvement is actually driven by an effect of the medication on the organ-specific fat depot,” he said.

Novo Nordisk and the University of Miami sponsored the study. Neither Dr. Iacobellis nor his coauthors disclosed conflicts of interest.

BOSTON – Liraglutide in combination with metformin reduced epicardial adipose tissue by nearly half within 6 months of treatment in people with type 2 diabetes, an effect independent of either body weight loss or glycemic control, according to a new study.

Epicardial adipose tissue (EAT) is the fat depot around the heart. While EAT has many cardioprotective properties, increased or excess EAT – seen more frequently in people with type 2 diabetes – has been linked to coronary artery disease, metabolic syndrome, diabetes, insulin resistance, and liver disease, according to a review by Gianluca Iacobellis, M.D., Ph.D., professor of clinical medicine in the division of endocrinology, diabetes and metabolism at the University of Miami (Nat. Rev. Endocrinol. 2015;11: 363-71).

More than a decade ago, Dr. Iacobellis proposed and validated ultrasound measurement of EAT thickness as marker of visceral fat and a therapeutic target (J. Clin. Endocrinol. Metab. 2003;88: 5163-8).

At the annual scientific sessions of the American Diabetes Association, Dr. Iacobellis presented preliminary findings from a case-control study in 35 patients with type 2 diabetes with body mass indexes greater than 27 kg/m² and hemoglobin A_1c levels no greater than 8% on metformin monotherapy.

Patients were randomized to remain on metformin or metformin plus the glucagon-like peptide-1 (GLP-1) analogue liraglutide subcutaneously up to 1.8 mg once daily for 6 months. EAT thickness was measured by ultrasound at baseline, 3 months, and 6 months, along with HbA_1c and BMI measures. In the liraglutide group (20 patients), EAT decreased significantly from 10.2 mm to 6.9 mm and 5.8 mm (P < 0.001) after 3 months and 6 months, respectively, for a 42% reduction at 6 months. The metformin-only group (15 patients) saw no reduction in EAT.

The EAT reduction seen in the intervention group was much greater than, and independent of, reductions in body weight or HbA_1c. Average BMI fell from 33 kg/m² at baseline to 31.8 kg/m² and 31.7 kg/m² at 3 months and 6 months, respectively, while HbA_1c declined 18% among patients on liraglutide.

The findings have important clinical and research implications, Dr. Iacobellis said in an interview. “Emerging evidence is pointing out that EAT as measured with reliable, safe, and cheap ultrasound can be a therapeutic target for medications directly or indirectly targeting the adipose tissue,” he said. And EAT can be measured in clinical settings, he added.

Moreover, there is a strong likelihood that further studies will show cardiovascular benefit associated with reductions in EAT, Dr. Iacobellis predicted.

“There is a direct cross-talk between the cardiac fat and the heart,” he said. “If you target the fat, if you’re able to modulate or to reduce the adipose tissue of the heart, you can directly modulate the myocardium and improve cardiovascular performance.”

Dr. Iacobellis’ study on liraglutide is ongoing, and the investigators are examining the effects of other classes of drugs, including the sodium-glucose cotransporter-2 (SLGT-2) inhibitors, on EAT in people with type 2 diabetes. Dr. Iacobellis said he did not know whether to consider the EAT reduction a likely class effect of GLP-1 analogue medications. It is biologically plausible, he added, because human adipose tissues express GLP-1 receptors.

Other studies are showing that exenatide may have some beneficial cardiovascular effect in patients with coronary artery disease, he said. “However, liraglutide seems to be the most effective in targeting the adipose tissue. There may be a class effect, but one drug could have a more prominent effect compared to others.”

It is possible that liraglutide’s metabolic and weight-loss benefits are in some way mediated by its effect on EAT and other visceral fat depots, Dr. Iacobellis observed, although further research will be needed to show that.

“We know that people lose weight on liraglutide, and we know they have an improvement in glucose control. But what we don’t know is whether the metabolic improvement is actually driven by an effect of the medication on the organ-specific fat depot,” he said.

Novo Nordisk and the University of Miami sponsored the study. Neither Dr. Iacobellis nor his coauthors disclosed conflicts of interest.

BOSTON – Using certified diabetes educators to intensify the therapeutic management of people with diabetes was feasible in the primary care setting and effective for improving hemoglobin A_1c in a cluster-randomized controlled trial.

Among 175 subjects enrolled from 15 participating centers, intensified evidence-based diabetes medication management protocols delivered by the certified diabetes educators (CDEs) were associated with significantly decreased HbA_1c (from 8.8% to 7.8%) at 1 year, while usual care in 65 patients was associated with a slight increase in HbA_1c, from 8.2% to 8.3%, Janice C. Zgibor, Ph.D. of the University of Pittsburgh reported at the annual scientific sessions of the American Diabetes Association.

Among those with an HbA_1c of 8% or greater at baseline, participation in the diabetes education group was associated with a greater likelihood of beginning a new medication during the course of the study, although the number of patients in the control group who received a new medication also increased over time, she said.

Participants in the study had a mean age of 61 years and were from a group of nonacademic primary care practices that researchers recruited and randomized to provide the intensified diabetes management protocols provided by CDEs or to provide usual care to their diabetic patients. All study participants had type 2 diabetes diagnosed at least 1 year earlier and had HbA_1c, blood pressure, and low-density lipoprotein cholesterol values above goal at last assessment.

The experimental treatment protocols were patient centered and took into consideration the patient’s lifestyle, psychosocial factors, risk for hypoglycemia or other adverse events, disease duration, comorbidities, and support systems that included financial resources. Education and support were delivered by a CDE during visits in the practice setting or by phone or e-mail. Usual care involved one monthly support group meeting held in the primary care practice or a nearby location and conducted by the CDE.

CDEs ordered medication changes and lab work as needed via the electronic health record, pending physician approval.

All protocols were evidence based and adhered to ADA standards of care and other guidelines and were updated as evidence changed, Dr. Zgibor noted.

The intervention group subjects continued to see significant HbA_1c improvement over 12 months, even after adjusting for differences in baseline HbA_1c between the groups. The greatest improvement in the intervention group was seen at 3 months. The control group experienced a slight improvement at that time, but HbA_1c in that group eventually started to increase.

“The absolute risk reduction was 30%. That means that an additional patient would improve due to treatment with the protocols, one wouldn’t change at all, and one would change on their own,” she said, adding that the findings suggest that it is feasible for diabetes educators to implement treatment protocols to intensify treatment.

The findings are timely, because while improvement has been seen over time in the proportion of persons with diabetes over the age of 20 years who meet goals for HbA_1c, blood pressure, and cholesterol, only 18% reach the goals for all three, she said, adding that many approaches, including physician prompts, patient reminders, and incentives for both providers and patients have been tried and have contributed to improvement. The Institute of Medicine has called for redesigned strategies and noted them as a health care system priority topic.

Another IOM priority topic is to compare the effectiveness of using allied health providers for chronic conditions, and the findings from several studies have demonstrated that these providers can be integrated into primary care to improve diabetes outcomes, she said.

The current study bolsters those findings.

“This approach was well accepted by our physicians and their staff. There were significant improvements in HbA_1c and they were sustained, treatment intensification was greatest in the intervention group after the first visit with the CDE, and over time the control group also experienced some treatment intensification. CDEs can be incorporated into the work flow of primary care. However, funding for dissemination and sustainability is problematic,” she said.

She noted, however, that the ADA and American Association of Diabetes Educators (AADE) recognition of self-management education provides a mechanism for reimbursement, but providers need to buy into the model.

Potential solutions for sustainability could include training office nurses to implement treatment intensification or alert providers to the need for treatment intensification, pooling resources (practices could share a CDE), and connection of CDEs to electronic health records to trigger alerts to providers to intensify treatment, she said.

Another University of Pittsburgh study presented at the ADA annual scientific sessions also demonstrated feasibility of a primary care approach to providing diabetes education, and reaffirmed the benefits of diabetes education in all patients with diabetes.

In that study, the feasibility of quality improvement approaches being used in other aspects of primary care, such as population management, electronic communication, and practice redesign, was evaluated in the context of diabetes education, according to Linda Siminerio, Ph.D., of the University of Pittsburgh.

Three CDEs were introduced to practices in their respective urban, suburban, and rural communities, and they proactively identified patients who might benefit from diabetes education, such as those at high risk for complications or with newly diagnosed diabetes, and those with frequent emergency department visits or hospitalizations. They arranged for referral and diabetes education visits and worked with primary care physicians on treatment plans.

Of 141 patients with type 2 diabetes who met with a CDE for diabetes education during the course of the study, those with pre-education HbA_1c levels at or below 7% maintained those levels at 6 months and at 12 months. Those with pre-education HbA_1c between 7% and 9% experienced significant reductions in HbA_1c at 6 months, and the levels were maintained at 12 months.

Those at highest risk – with pre-education HbA_1c greater than 9% – also experienced significant reductions in HbA_1c at 6 months, with maintenance of the improvements at 12 months.

Overall the population also experienced significant improvements in triglycerides and total cholesterol levels, but systolic blood pressure and weight did not change significantly.

“These findings demonstrate the feasibility and potential effectiveness of this novel education practice–based approach to improving glycemia in type 2 diabetes patients and lowering triglycerides (which could be indicative of a positive impact from lifestyle changes that were supported by the diabetes educator), reaffirming the benefit of education in all patients, particularly those at highest risk,” said Dr. Siminerio, who also is chair of the National Diabetes Education Program.

This model, known as Glucose to Goal program, reflected a team approach with the provider and educator both contributing to possible initiation of supportive therapy, she said, noting that the approach was somewhat similar to that used in Dr. Zgibor’s study, except protocols weren’t used.

“That’s because we didn’t have them available, but we hope to have them soon. We will be partnering on this and deploying this model across our whole health system,” she said.

Dr. Siminerio noted a number of “anecdotal undocumented successes,” including patient reports of better communication and support, educator reports of an increase in patient access and volume of patients reached, and primary care physician support for the program and reports of quality improvement and reduced workload.

This approach holds promise to support diabetes care that is cost effective and scalable, she said, noting that it “integrates team care while leveraging existing infrastructure.”

Additional research is needed to assess long-term effectiveness, she said, noting that developing effective diabetes education programs is imperative, as diabetes self-management and time spent with diabetes educators has repeatedly been shown to improve clinical, psychological and behavioral outcomes, yet diabetes education is underutilized.

“Nationally, only 6.8% of individuals with newly diagnosed type 2 diabetes participate in diabetes self-management education within 12 months of diagnosis, and, only 4% of Medicare participants are reported to have received DSME [diabetes self-management education] and/or medical nutrition therapy,” she said.

Of note, the ADA and AADE, along with the Academy of Nutrition and Dietetics, released a joint position statement on DSME during the ADA annual scientific sessions.

The statement, jointly published online in Diabetes Care, The Diabetes Educator, and the Journal of the Academy of Nutrition and Dietetics, highlighted four critical times for assessing the need for DSME and support referral: at diagnosis, on an annual basis, when new complicating factors influence self-management and transitions in care occur. The statement provides guidance on the type of information and support patients might need at theses “critical junctures,” and outlines the appropriate content, roles, and action steps for both the referring provider and the diabetes educators (Diabetes Care 2015 June 5 [doi:10.2337/dc15-0730]).

A major gap in diabetes education is in the area of referrals; there aren’t many providers routinely referring patients to diabetes educators, because either they don’t know how to refer, can’t find an educator, or aren’t aware of the value of diabetes education, according to a press release on the statement.

“Yet those referrals are critical,” Dr. Siminerio said in the release.

“Referrals influence patient behavior a great deal. When providers refer patients to diabetes education, we see an 83% participation rate, but without those referrals participation is abysmally low. If patients believe their physicians think diabetes education is important, they take it a lot more seriously. Patients trust their providers,” she said.

The Remedy Study was funded by the ADA. Dr. Zgibor reported having no other disclosures. Dr. Siminerio reported receiving research support from Becton, Dickinson and Co.

[email protected]

BOSTON – Using certified diabetes educators to intensify the therapeutic management of people with diabetes was feasible in the primary care setting and effective for improving hemoglobin A_1c in a cluster-randomized controlled trial.

Among 175 subjects enrolled from 15 participating centers, intensified evidence-based diabetes medication management protocols delivered by the certified diabetes educators (CDEs) were associated with significantly decreased HbA_1c (from 8.8% to 7.8%) at 1 year, while usual care in 65 patients was associated with a slight increase in HbA_1c, from 8.2% to 8.3%, Janice C. Zgibor, Ph.D. of the University of Pittsburgh reported at the annual scientific sessions of the American Diabetes Association.

Among those with an HbA_1c of 8% or greater at baseline, participation in the diabetes education group was associated with a greater likelihood of beginning a new medication during the course of the study, although the number of patients in the control group who received a new medication also increased over time, she said.

Participants in the study had a mean age of 61 years and were from a group of nonacademic primary care practices that researchers recruited and randomized to provide the intensified diabetes management protocols provided by CDEs or to provide usual care to their diabetic patients. All study participants had type 2 diabetes diagnosed at least 1 year earlier and had HbA_1c, blood pressure, and low-density lipoprotein cholesterol values above goal at last assessment.

The experimental treatment protocols were patient centered and took into consideration the patient’s lifestyle, psychosocial factors, risk for hypoglycemia or other adverse events, disease duration, comorbidities, and support systems that included financial resources. Education and support were delivered by a CDE during visits in the practice setting or by phone or e-mail. Usual care involved one monthly support group meeting held in the primary care practice or a nearby location and conducted by the CDE.

CDEs ordered medication changes and lab work as needed via the electronic health record, pending physician approval.

All protocols were evidence based and adhered to ADA standards of care and other guidelines and were updated as evidence changed, Dr. Zgibor noted.

The intervention group subjects continued to see significant HbA_1c improvement over 12 months, even after adjusting for differences in baseline HbA_1c between the groups. The greatest improvement in the intervention group was seen at 3 months. The control group experienced a slight improvement at that time, but HbA_1c in that group eventually started to increase.

“The absolute risk reduction was 30%. That means that an additional patient would improve due to treatment with the protocols, one wouldn’t change at all, and one would change on their own,” she said, adding that the findings suggest that it is feasible for diabetes educators to implement treatment protocols to intensify treatment.

The findings are timely, because while improvement has been seen over time in the proportion of persons with diabetes over the age of 20 years who meet goals for HbA_1c, blood pressure, and cholesterol, only 18% reach the goals for all three, she said, adding that many approaches, including physician prompts, patient reminders, and incentives for both providers and patients have been tried and have contributed to improvement. The Institute of Medicine has called for redesigned strategies and noted them as a health care system priority topic.

Another IOM priority topic is to compare the effectiveness of using allied health providers for chronic conditions, and the findings from several studies have demonstrated that these providers can be integrated into primary care to improve diabetes outcomes, she said.

The current study bolsters those findings.

“This approach was well accepted by our physicians and their staff. There were significant improvements in HbA_1c and they were sustained, treatment intensification was greatest in the intervention group after the first visit with the CDE, and over time the control group also experienced some treatment intensification. CDEs can be incorporated into the work flow of primary care. However, funding for dissemination and sustainability is problematic,” she said.

She noted, however, that the ADA and American Association of Diabetes Educators (AADE) recognition of self-management education provides a mechanism for reimbursement, but providers need to buy into the model.

Potential solutions for sustainability could include training office nurses to implement treatment intensification or alert providers to the need for treatment intensification, pooling resources (practices could share a CDE), and connection of CDEs to electronic health records to trigger alerts to providers to intensify treatment, she said.

Another University of Pittsburgh study presented at the ADA annual scientific sessions also demonstrated feasibility of a primary care approach to providing diabetes education, and reaffirmed the benefits of diabetes education in all patients with diabetes.

In that study, the feasibility of quality improvement approaches being used in other aspects of primary care, such as population management, electronic communication, and practice redesign, was evaluated in the context of diabetes education, according to Linda Siminerio, Ph.D., of the University of Pittsburgh.

Three CDEs were introduced to practices in their respective urban, suburban, and rural communities, and they proactively identified patients who might benefit from diabetes education, such as those at high risk for complications or with newly diagnosed diabetes, and those with frequent emergency department visits or hospitalizations. They arranged for referral and diabetes education visits and worked with primary care physicians on treatment plans.

Of 141 patients with type 2 diabetes who met with a CDE for diabetes education during the course of the study, those with pre-education HbA_1c levels at or below 7% maintained those levels at 6 months and at 12 months. Those with pre-education HbA_1c between 7% and 9% experienced significant reductions in HbA_1c at 6 months, and the levels were maintained at 12 months.

Those at highest risk – with pre-education HbA_1c greater than 9% – also experienced significant reductions in HbA_1c at 6 months, with maintenance of the improvements at 12 months.

Overall the population also experienced significant improvements in triglycerides and total cholesterol levels, but systolic blood pressure and weight did not change significantly.

“These findings demonstrate the feasibility and potential effectiveness of this novel education practice–based approach to improving glycemia in type 2 diabetes patients and lowering triglycerides (which could be indicative of a positive impact from lifestyle changes that were supported by the diabetes educator), reaffirming the benefit of education in all patients, particularly those at highest risk,” said Dr. Siminerio, who also is chair of the National Diabetes Education Program.

This model, known as Glucose to Goal program, reflected a team approach with the provider and educator both contributing to possible initiation of supportive therapy, she said, noting that the approach was somewhat similar to that used in Dr. Zgibor’s study, except protocols weren’t used.

“That’s because we didn’t have them available, but we hope to have them soon. We will be partnering on this and deploying this model across our whole health system,” she said.

Dr. Siminerio noted a number of “anecdotal undocumented successes,” including patient reports of better communication and support, educator reports of an increase in patient access and volume of patients reached, and primary care physician support for the program and reports of quality improvement and reduced workload.

This approach holds promise to support diabetes care that is cost effective and scalable, she said, noting that it “integrates team care while leveraging existing infrastructure.”

Additional research is needed to assess long-term effectiveness, she said, noting that developing effective diabetes education programs is imperative, as diabetes self-management and time spent with diabetes educators has repeatedly been shown to improve clinical, psychological and behavioral outcomes, yet diabetes education is underutilized.

“Nationally, only 6.8% of individuals with newly diagnosed type 2 diabetes participate in diabetes self-management education within 12 months of diagnosis, and, only 4% of Medicare participants are reported to have received DSME [diabetes self-management education] and/or medical nutrition therapy,” she said.

Of note, the ADA and AADE, along with the Academy of Nutrition and Dietetics, released a joint position statement on DSME during the ADA annual scientific sessions.

The statement, jointly published online in Diabetes Care, The Diabetes Educator, and the Journal of the Academy of Nutrition and Dietetics, highlighted four critical times for assessing the need for DSME and support referral: at diagnosis, on an annual basis, when new complicating factors influence self-management and transitions in care occur. The statement provides guidance on the type of information and support patients might need at theses “critical junctures,” and outlines the appropriate content, roles, and action steps for both the referring provider and the diabetes educators (Diabetes Care 2015 June 5 [doi:10.2337/dc15-0730]).

A major gap in diabetes education is in the area of referrals; there aren’t many providers routinely referring patients to diabetes educators, because either they don’t know how to refer, can’t find an educator, or aren’t aware of the value of diabetes education, according to a press release on the statement.

“Yet those referrals are critical,” Dr. Siminerio said in the release.

“Referrals influence patient behavior a great deal. When providers refer patients to diabetes education, we see an 83% participation rate, but without those referrals participation is abysmally low. If patients believe their physicians think diabetes education is important, they take it a lot more seriously. Patients trust their providers,” she said.

The Remedy Study was funded by the ADA. Dr. Zgibor reported having no other disclosures. Dr. Siminerio reported receiving research support from Becton, Dickinson and Co.

[email protected]

BOSTON – Using certified diabetes educators to intensify the therapeutic management of people with diabetes was feasible in the primary care setting and effective for improving hemoglobin A_1c in a cluster-randomized controlled trial.

Among 175 subjects enrolled from 15 participating centers, intensified evidence-based diabetes medication management protocols delivered by the certified diabetes educators (CDEs) were associated with significantly decreased HbA_1c (from 8.8% to 7.8%) at 1 year, while usual care in 65 patients was associated with a slight increase in HbA_1c, from 8.2% to 8.3%, Janice C. Zgibor, Ph.D. of the University of Pittsburgh reported at the annual scientific sessions of the American Diabetes Association.

Among those with an HbA_1c of 8% or greater at baseline, participation in the diabetes education group was associated with a greater likelihood of beginning a new medication during the course of the study, although the number of patients in the control group who received a new medication also increased over time, she said.

Participants in the study had a mean age of 61 years and were from a group of nonacademic primary care practices that researchers recruited and randomized to provide the intensified diabetes management protocols provided by CDEs or to provide usual care to their diabetic patients. All study participants had type 2 diabetes diagnosed at least 1 year earlier and had HbA_1c, blood pressure, and low-density lipoprotein cholesterol values above goal at last assessment.

The experimental treatment protocols were patient centered and took into consideration the patient’s lifestyle, psychosocial factors, risk for hypoglycemia or other adverse events, disease duration, comorbidities, and support systems that included financial resources. Education and support were delivered by a CDE during visits in the practice setting or by phone or e-mail. Usual care involved one monthly support group meeting held in the primary care practice or a nearby location and conducted by the CDE.

CDEs ordered medication changes and lab work as needed via the electronic health record, pending physician approval.

All protocols were evidence based and adhered to ADA standards of care and other guidelines and were updated as evidence changed, Dr. Zgibor noted.

The intervention group subjects continued to see significant HbA_1c improvement over 12 months, even after adjusting for differences in baseline HbA_1c between the groups. The greatest improvement in the intervention group was seen at 3 months. The control group experienced a slight improvement at that time, but HbA_1c in that group eventually started to increase.

“The absolute risk reduction was 30%. That means that an additional patient would improve due to treatment with the protocols, one wouldn’t change at all, and one would change on their own,” she said, adding that the findings suggest that it is feasible for diabetes educators to implement treatment protocols to intensify treatment.

The findings are timely, because while improvement has been seen over time in the proportion of persons with diabetes over the age of 20 years who meet goals for HbA_1c, blood pressure, and cholesterol, only 18% reach the goals for all three, she said, adding that many approaches, including physician prompts, patient reminders, and incentives for both providers and patients have been tried and have contributed to improvement. The Institute of Medicine has called for redesigned strategies and noted them as a health care system priority topic.

Another IOM priority topic is to compare the effectiveness of using allied health providers for chronic conditions, and the findings from several studies have demonstrated that these providers can be integrated into primary care to improve diabetes outcomes, she said.

The current study bolsters those findings.

“This approach was well accepted by our physicians and their staff. There were significant improvements in HbA_1c and they were sustained, treatment intensification was greatest in the intervention group after the first visit with the CDE, and over time the control group also experienced some treatment intensification. CDEs can be incorporated into the work flow of primary care. However, funding for dissemination and sustainability is problematic,” she said.

She noted, however, that the ADA and American Association of Diabetes Educators (AADE) recognition of self-management education provides a mechanism for reimbursement, but providers need to buy into the model.

Potential solutions for sustainability could include training office nurses to implement treatment intensification or alert providers to the need for treatment intensification, pooling resources (practices could share a CDE), and connection of CDEs to electronic health records to trigger alerts to providers to intensify treatment, she said.

Another University of Pittsburgh study presented at the ADA annual scientific sessions also demonstrated feasibility of a primary care approach to providing diabetes education, and reaffirmed the benefits of diabetes education in all patients with diabetes.

In that study, the feasibility of quality improvement approaches being used in other aspects of primary care, such as population management, electronic communication, and practice redesign, was evaluated in the context of diabetes education, according to Linda Siminerio, Ph.D., of the University of Pittsburgh.

Three CDEs were introduced to practices in their respective urban, suburban, and rural communities, and they proactively identified patients who might benefit from diabetes education, such as those at high risk for complications or with newly diagnosed diabetes, and those with frequent emergency department visits or hospitalizations. They arranged for referral and diabetes education visits and worked with primary care physicians on treatment plans.

Of 141 patients with type 2 diabetes who met with a CDE for diabetes education during the course of the study, those with pre-education HbA_1c levels at or below 7% maintained those levels at 6 months and at 12 months. Those with pre-education HbA_1c between 7% and 9% experienced significant reductions in HbA_1c at 6 months, and the levels were maintained at 12 months.

Those at highest risk – with pre-education HbA_1c greater than 9% – also experienced significant reductions in HbA_1c at 6 months, with maintenance of the improvements at 12 months.

Overall the population also experienced significant improvements in triglycerides and total cholesterol levels, but systolic blood pressure and weight did not change significantly.

“These findings demonstrate the feasibility and potential effectiveness of this novel education practice–based approach to improving glycemia in type 2 diabetes patients and lowering triglycerides (which could be indicative of a positive impact from lifestyle changes that were supported by the diabetes educator), reaffirming the benefit of education in all patients, particularly those at highest risk,” said Dr. Siminerio, who also is chair of the National Diabetes Education Program.

This model, known as Glucose to Goal program, reflected a team approach with the provider and educator both contributing to possible initiation of supportive therapy, she said, noting that the approach was somewhat similar to that used in Dr. Zgibor’s study, except protocols weren’t used.

“That’s because we didn’t have them available, but we hope to have them soon. We will be partnering on this and deploying this model across our whole health system,” she said.

Dr. Siminerio noted a number of “anecdotal undocumented successes,” including patient reports of better communication and support, educator reports of an increase in patient access and volume of patients reached, and primary care physician support for the program and reports of quality improvement and reduced workload.

This approach holds promise to support diabetes care that is cost effective and scalable, she said, noting that it “integrates team care while leveraging existing infrastructure.”

Additional research is needed to assess long-term effectiveness, she said, noting that developing effective diabetes education programs is imperative, as diabetes self-management and time spent with diabetes educators has repeatedly been shown to improve clinical, psychological and behavioral outcomes, yet diabetes education is underutilized.

“Nationally, only 6.8% of individuals with newly diagnosed type 2 diabetes participate in diabetes self-management education within 12 months of diagnosis, and, only 4% of Medicare participants are reported to have received DSME [diabetes self-management education] and/or medical nutrition therapy,” she said.

Of note, the ADA and AADE, along with the Academy of Nutrition and Dietetics, released a joint position statement on DSME during the ADA annual scientific sessions.

The statement, jointly published online in Diabetes Care, The Diabetes Educator, and the Journal of the Academy of Nutrition and Dietetics, highlighted four critical times for assessing the need for DSME and support referral: at diagnosis, on an annual basis, when new complicating factors influence self-management and transitions in care occur. The statement provides guidance on the type of information and support patients might need at theses “critical junctures,” and outlines the appropriate content, roles, and action steps for both the referring provider and the diabetes educators (Diabetes Care 2015 June 5 [doi:10.2337/dc15-0730]).

A major gap in diabetes education is in the area of referrals; there aren’t many providers routinely referring patients to diabetes educators, because either they don’t know how to refer, can’t find an educator, or aren’t aware of the value of diabetes education, according to a press release on the statement.

“Yet those referrals are critical,” Dr. Siminerio said in the release.

“Referrals influence patient behavior a great deal. When providers refer patients to diabetes education, we see an 83% participation rate, but without those referrals participation is abysmally low. If patients believe their physicians think diabetes education is important, they take it a lot more seriously. Patients trust their providers,” she said.

The Remedy Study was funded by the ADA. Dr. Zgibor reported having no other disclosures. Dr. Siminerio reported receiving research support from Becton, Dickinson and Co.

[email protected]

BOSTON – Intensive behavioral counseling as recommended by the U.S. Preventive Services Task Force for obese and overweight adults at risk for cardiovascular disease would increase quality-adjusted life years in a cost-effective manner in the U.S. population, according to a lifetime disease progression model.

For each person receiving the intervention, the model showed an average increase in quality-adjusted life years (QALY) of 0.019 at a cost of $197 over 25 years. The incremental cost-effectiveness ratio was $10,500 per QALY, Ping Zhang, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, reported at the annual scientific sessions of the American Diabetes Association.

©Jami Garrison/Thinkstock.com

“Given a conventional willingness to pay at $50,000 per QALY, we would say it’s pretty cost-effective,” Dr. Zhang said, noting that in this model representing 101 million U.S. adults, 23,000 cases of cardiovascular disease and 671,000 cases of diabetes would be prevented at a total intervention cost of $58 billion.

Given that “huge amount,” he and his colleagues stratified individuals based on body mass index and cardiovascular disease risk factors to determine who would benefit most from intervention. They found the intervention to be cost saving or above cost saving in obese individuals with impaired fasting glucose (with the greatest benefits in those with at least two additional risk factors), and to be cost-effective or above cost-effective in obese individuals without impaired fasting glucose and in overweight individuals with impaired fasting glucose, he said.

For those who are overweight but who do not have impaired fasting glucose, the cost of intervention was above $50,000 and thus not considered cost-effective.

The USPSTF recommendations, made in August 2014 based on health benefits of such counseling as demonstrated in randomized clinical trials, call for intensive behavioral counseling interventions to promote a healthful diet and physical activity in overweight and obese adults with at least one cardiovascular disease risk factor, such as hypertension, dyslipidemia, impaired fasting glucose, or metabolic syndrome.

To examine the long-term health implications and cost-effectiveness of the recommendations, Dr. Zhang and his colleagues estimated baseline risk factor levels and population characteristics based on 2005-2012 National Health and Nutrition Examination Survey (NHANES) data, and based assumptions about the effectiveness of the interventions on USPSTF data showing a 54% reduction in risk of diabetes, a 2.06 mm Hg reduction in systolic blood pressure, a 5.43 mg/dL reduction in total cholesterol, and 1.0 kg/m² reduction in body mass index after a median of 16 sessions in 12 months.

Costs of counseling were assumed to be $576 per person based on reported estimates, and future QALYs and costs were discounted at 3% per year.

Dr. Zhang recommended prioritizing interventions. If resources are limited, invest first in those with the highest risk: obese adults with impaired fasting glucose and hypertension, followed by those who are obese and have impaired fasting glucose, he advised.

Dr. Zhang reported having no disclosures.

[email protected]

BOSTON – Intensive behavioral counseling as recommended by the U.S. Preventive Services Task Force for obese and overweight adults at risk for cardiovascular disease would increase quality-adjusted life years in a cost-effective manner in the U.S. population, according to a lifetime disease progression model.

For each person receiving the intervention, the model showed an average increase in quality-adjusted life years (QALY) of 0.019 at a cost of $197 over 25 years. The incremental cost-effectiveness ratio was $10,500 per QALY, Ping Zhang, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, reported at the annual scientific sessions of the American Diabetes Association.

©Jami Garrison/Thinkstock.com

“Given a conventional willingness to pay at $50,000 per QALY, we would say it’s pretty cost-effective,” Dr. Zhang said, noting that in this model representing 101 million U.S. adults, 23,000 cases of cardiovascular disease and 671,000 cases of diabetes would be prevented at a total intervention cost of $58 billion.

Given that “huge amount,” he and his colleagues stratified individuals based on body mass index and cardiovascular disease risk factors to determine who would benefit most from intervention. They found the intervention to be cost saving or above cost saving in obese individuals with impaired fasting glucose (with the greatest benefits in those with at least two additional risk factors), and to be cost-effective or above cost-effective in obese individuals without impaired fasting glucose and in overweight individuals with impaired fasting glucose, he said.

For those who are overweight but who do not have impaired fasting glucose, the cost of intervention was above $50,000 and thus not considered cost-effective.

The USPSTF recommendations, made in August 2014 based on health benefits of such counseling as demonstrated in randomized clinical trials, call for intensive behavioral counseling interventions to promote a healthful diet and physical activity in overweight and obese adults with at least one cardiovascular disease risk factor, such as hypertension, dyslipidemia, impaired fasting glucose, or metabolic syndrome.

To examine the long-term health implications and cost-effectiveness of the recommendations, Dr. Zhang and his colleagues estimated baseline risk factor levels and population characteristics based on 2005-2012 National Health and Nutrition Examination Survey (NHANES) data, and based assumptions about the effectiveness of the interventions on USPSTF data showing a 54% reduction in risk of diabetes, a 2.06 mm Hg reduction in systolic blood pressure, a 5.43 mg/dL reduction in total cholesterol, and 1.0 kg/m² reduction in body mass index after a median of 16 sessions in 12 months.

Costs of counseling were assumed to be $576 per person based on reported estimates, and future QALYs and costs were discounted at 3% per year.

Dr. Zhang recommended prioritizing interventions. If resources are limited, invest first in those with the highest risk: obese adults with impaired fasting glucose and hypertension, followed by those who are obese and have impaired fasting glucose, he advised.

Dr. Zhang reported having no disclosures.

[email protected]

BOSTON – Intensive behavioral counseling as recommended by the U.S. Preventive Services Task Force for obese and overweight adults at risk for cardiovascular disease would increase quality-adjusted life years in a cost-effective manner in the U.S. population, according to a lifetime disease progression model.

For each person receiving the intervention, the model showed an average increase in quality-adjusted life years (QALY) of 0.019 at a cost of $197 over 25 years. The incremental cost-effectiveness ratio was $10,500 per QALY, Ping Zhang, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, reported at the annual scientific sessions of the American Diabetes Association.

©Jami Garrison/Thinkstock.com

“Given a conventional willingness to pay at $50,000 per QALY, we would say it’s pretty cost-effective,” Dr. Zhang said, noting that in this model representing 101 million U.S. adults, 23,000 cases of cardiovascular disease and 671,000 cases of diabetes would be prevented at a total intervention cost of $58 billion.

Given that “huge amount,” he and his colleagues stratified individuals based on body mass index and cardiovascular disease risk factors to determine who would benefit most from intervention. They found the intervention to be cost saving or above cost saving in obese individuals with impaired fasting glucose (with the greatest benefits in those with at least two additional risk factors), and to be cost-effective or above cost-effective in obese individuals without impaired fasting glucose and in overweight individuals with impaired fasting glucose, he said.

For those who are overweight but who do not have impaired fasting glucose, the cost of intervention was above $50,000 and thus not considered cost-effective.

The USPSTF recommendations, made in August 2014 based on health benefits of such counseling as demonstrated in randomized clinical trials, call for intensive behavioral counseling interventions to promote a healthful diet and physical activity in overweight and obese adults with at least one cardiovascular disease risk factor, such as hypertension, dyslipidemia, impaired fasting glucose, or metabolic syndrome.

To examine the long-term health implications and cost-effectiveness of the recommendations, Dr. Zhang and his colleagues estimated baseline risk factor levels and population characteristics based on 2005-2012 National Health and Nutrition Examination Survey (NHANES) data, and based assumptions about the effectiveness of the interventions on USPSTF data showing a 54% reduction in risk of diabetes, a 2.06 mm Hg reduction in systolic blood pressure, a 5.43 mg/dL reduction in total cholesterol, and 1.0 kg/m² reduction in body mass index after a median of 16 sessions in 12 months.

Costs of counseling were assumed to be $576 per person based on reported estimates, and future QALYs and costs were discounted at 3% per year.

Dr. Zhang recommended prioritizing interventions. If resources are limited, invest first in those with the highest risk: obese adults with impaired fasting glucose and hypertension, followed by those who are obese and have impaired fasting glucose, he advised.

Dr. Zhang reported having no disclosures.

[email protected]

Among obese patients who underwent bariatric surgery 40% achieved at least partial remission of type 2 diabetes mellitus, compared with no patients who underwent a nonsurgical lifestyle intervention program, investigators reported online July 1 in JAMA Surgery.

The randomized clinical trial of 61 patients offers “further important evidence that at longer-term follow-up of 3 years, surgical treatments, including Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding, are superior to lifestyle intervention alone for the remission of type 2 diabetes mellitus in obese individuals, including those with a body mass index (BMI) between 30 and 35 [kg/m^2],” said Dr. Anita Courcoulas at the University of Pittsburgh Medical Center and her associates. But further studies will be needed to explore exactly how bariatric surgery affects diabetes and the effect of these procedures on the microvascular and macrovascular complications of diabetes, the investigators added (JAMA Surg. 2015 July 1 [doi:10.1001/jamasurg.2015.1534]).

Several studies have reported major improvements in type 2 diabetes mellitus (T2DM) after bariatric surgery, but did not assess long-term efficacy or safety compared with lifestyle and medical management, the researchers noted. To fill that gap, they randomized obese middle-aged adults with T2DM to either an intensive lifestyle weight loss program for 1 year followed by a 2-year low-level lifestyle intervention program, or to Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB) followed by the low-level lifestyle intervention program during years 2 and 3.

After 3 years, 40% of RYGB patients and 29% of LAGB patients were fully or partially remitted, compared with none of the control group (P = .004), the investigators reported. The bariatric surgery groups did not significantly differ in terms of complete remission, but 65% of RYGB patients and 33% of LAGB patients were able to stop all insulin and oral diabetes medications, compared with none of the control group (P < .001). Also, RYGB patients lost an average of 25% of their baseline body weight, compared with 15% for LAGB (P = .0002) and only 5.7% for the lifestyle-only control group (P < .0001).

At baseline, patients averaged 100.5 kg (standard deviation, 13.7 kg) in body weight, mean hemoglobin A_1c level was 7.8% (standard deviation, 1.9%), average fasting plasma glucose level was 171.3 (72.5) mg per dL, the investigators said. “One important aspect of this study was that more than 40% of the sample were individuals with class I obesity (BMI ≥ 30), for whom data in the literature are largely lacking,” they added. Adverse events were uncommon after the first year, but RYGB was linked to significant drops in lean muscle and bone mass that will need further study, they noted.

The National Institutes of Health and the University of Pittsburgh Medical Center funded the study. Dr. Courcoulas reported research support from Nutrisystem, J&J Ethicon, and Covidien, and consulting relationships with Ethicon and Apollo Endosurgery. Two coauthors reported relationships with the Obesity Society/Nutrisystem, Jawbone/BodyMedia, and Weight Watchers. The other investigators declared no conflicts of interest.

Among obese patients who underwent bariatric surgery 40% achieved at least partial remission of type 2 diabetes mellitus, compared with no patients who underwent a nonsurgical lifestyle intervention program, investigators reported online July 1 in JAMA Surgery.

The randomized clinical trial of 61 patients offers “further important evidence that at longer-term follow-up of 3 years, surgical treatments, including Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding, are superior to lifestyle intervention alone for the remission of type 2 diabetes mellitus in obese individuals, including those with a body mass index (BMI) between 30 and 35 [kg/m^2],” said Dr. Anita Courcoulas at the University of Pittsburgh Medical Center and her associates. But further studies will be needed to explore exactly how bariatric surgery affects diabetes and the effect of these procedures on the microvascular and macrovascular complications of diabetes, the investigators added (JAMA Surg. 2015 July 1 [doi:10.1001/jamasurg.2015.1534]).

Several studies have reported major improvements in type 2 diabetes mellitus (T2DM) after bariatric surgery, but did not assess long-term efficacy or safety compared with lifestyle and medical management, the researchers noted. To fill that gap, they randomized obese middle-aged adults with T2DM to either an intensive lifestyle weight loss program for 1 year followed by a 2-year low-level lifestyle intervention program, or to Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB) followed by the low-level lifestyle intervention program during years 2 and 3.

After 3 years, 40% of RYGB patients and 29% of LAGB patients were fully or partially remitted, compared with none of the control group (P = .004), the investigators reported. The bariatric surgery groups did not significantly differ in terms of complete remission, but 65% of RYGB patients and 33% of LAGB patients were able to stop all insulin and oral diabetes medications, compared with none of the control group (P < .001). Also, RYGB patients lost an average of 25% of their baseline body weight, compared with 15% for LAGB (P = .0002) and only 5.7% for the lifestyle-only control group (P < .0001).

At baseline, patients averaged 100.5 kg (standard deviation, 13.7 kg) in body weight, mean hemoglobin A_1c level was 7.8% (standard deviation, 1.9%), average fasting plasma glucose level was 171.3 (72.5) mg per dL, the investigators said. “One important aspect of this study was that more than 40% of the sample were individuals with class I obesity (BMI ≥ 30), for whom data in the literature are largely lacking,” they added. Adverse events were uncommon after the first year, but RYGB was linked to significant drops in lean muscle and bone mass that will need further study, they noted.

The National Institutes of Health and the University of Pittsburgh Medical Center funded the study. Dr. Courcoulas reported research support from Nutrisystem, J&J Ethicon, and Covidien, and consulting relationships with Ethicon and Apollo Endosurgery. Two coauthors reported relationships with the Obesity Society/Nutrisystem, Jawbone/BodyMedia, and Weight Watchers. The other investigators declared no conflicts of interest.

Among obese patients who underwent bariatric surgery 40% achieved at least partial remission of type 2 diabetes mellitus, compared with no patients who underwent a nonsurgical lifestyle intervention program, investigators reported online July 1 in JAMA Surgery.

The randomized clinical trial of 61 patients offers “further important evidence that at longer-term follow-up of 3 years, surgical treatments, including Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding, are superior to lifestyle intervention alone for the remission of type 2 diabetes mellitus in obese individuals, including those with a body mass index (BMI) between 30 and 35 [kg/m^2],” said Dr. Anita Courcoulas at the University of Pittsburgh Medical Center and her associates. But further studies will be needed to explore exactly how bariatric surgery affects diabetes and the effect of these procedures on the microvascular and macrovascular complications of diabetes, the investigators added (JAMA Surg. 2015 July 1 [doi:10.1001/jamasurg.2015.1534]).

Several studies have reported major improvements in type 2 diabetes mellitus (T2DM) after bariatric surgery, but did not assess long-term efficacy or safety compared with lifestyle and medical management, the researchers noted. To fill that gap, they randomized obese middle-aged adults with T2DM to either an intensive lifestyle weight loss program for 1 year followed by a 2-year low-level lifestyle intervention program, or to Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB) followed by the low-level lifestyle intervention program during years 2 and 3.

After 3 years, 40% of RYGB patients and 29% of LAGB patients were fully or partially remitted, compared with none of the control group (P = .004), the investigators reported. The bariatric surgery groups did not significantly differ in terms of complete remission, but 65% of RYGB patients and 33% of LAGB patients were able to stop all insulin and oral diabetes medications, compared with none of the control group (P < .001). Also, RYGB patients lost an average of 25% of their baseline body weight, compared with 15% for LAGB (P = .0002) and only 5.7% for the lifestyle-only control group (P < .0001).

At baseline, patients averaged 100.5 kg (standard deviation, 13.7 kg) in body weight, mean hemoglobin A_1c level was 7.8% (standard deviation, 1.9%), average fasting plasma glucose level was 171.3 (72.5) mg per dL, the investigators said. “One important aspect of this study was that more than 40% of the sample were individuals with class I obesity (BMI ≥ 30), for whom data in the literature are largely lacking,” they added. Adverse events were uncommon after the first year, but RYGB was linked to significant drops in lean muscle and bone mass that will need further study, they noted.

The National Institutes of Health and the University of Pittsburgh Medical Center funded the study. Dr. Courcoulas reported research support from Nutrisystem, J&J Ethicon, and Covidien, and consulting relationships with Ethicon and Apollo Endosurgery. Two coauthors reported relationships with the Obesity Society/Nutrisystem, Jawbone/BodyMedia, and Weight Watchers. The other investigators declared no conflicts of interest.

WASHINGTON – How do naltrexone and naloxone work in the brain to help treat opioid and alcohol dependence, and what are the implications for those who have what Dr. Mark S. Gold of the department of psychiatry at Washington University in St. Louis calls “food addiction”? In this video, recorded at the Summit in Neurology & Psychiatry held by the Global Academy for Medical Education, Dr. Gold discusses the mechanism of action for these opioid agonists and their role in addiction treatment. The Global Academy and this news organization are owned by the same company.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – How do naltrexone and naloxone work in the brain to help treat opioid and alcohol dependence, and what are the implications for those who have what Dr. Mark S. Gold of the department of psychiatry at Washington University in St. Louis calls “food addiction”? In this video, recorded at the Summit in Neurology & Psychiatry held by the Global Academy for Medical Education, Dr. Gold discusses the mechanism of action for these opioid agonists and their role in addiction treatment. The Global Academy and this news organization are owned by the same company.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – How do naltrexone and naloxone work in the brain to help treat opioid and alcohol dependence, and what are the implications for those who have what Dr. Mark S. Gold of the department of psychiatry at Washington University in St. Louis calls “food addiction”? In this video, recorded at the Summit in Neurology & Psychiatry held by the Global Academy for Medical Education, Dr. Gold discusses the mechanism of action for these opioid agonists and their role in addiction treatment. The Global Academy and this news organization are owned by the same company.

[email protected]

On Twitter @whitneymcknight

BOSTON – Rural African-American women with poorly controlled type 2 diabetes saw significant improvements in glycemic control when their disease-related distress levels dropped.

The findings, from a randomized, controlled trial of 150 women, add to a growing body of evidence that diabetes-related emotional distress – which can include concerns related to disease management, a fear of becoming sicker, and a sense of being isolated or overwhelmed as a result of the disease – bears on clinical outcomes in type 2 diabetes, particularly HbA_1c.

©Tashatuvango/Thinkstockphotos.com

A validated diabetes distress score was introduced a decade ago for use in clinical research (Diabetes Care 2005;28:626-31), and last year investigators in San Francisco showed that people with lower stress related to their diabetic care regimens had significantly lower HbA_1c and better medication adherence (Diabetes Care 2014;37:617-24).

At the annual scientific sessions of the American Diabetes Association, Doyle Cummings, Pharm.D., of East Carolina University in Greenville, N.C., presented data from the EMPOWER study, a prospective, randomized clinical trial among rural African-American women in North Carolina. Dr. Cummings reported a similar association between distress and HbA_1c.

The EMPOWER study randomized 150 mostly low-income African-American women with uncontrolled type 2 diabetes (mean age 55, mean 10.9 years with diabetes, and mean HbA_1c of 9.1) to an in-person or phone-delivered lifestyle intervention delivered by community health workers or mailed written advice. The in-person or phone-delivered intervention involved 16 sessions of training in nutrition, physical activity, and self-monitoring, emphasizing small and incremental changes.

The investigators looked at weight and HbA_1c at 12 months, compared with baseline in both groups, and found modest improvements for both measures in the active intervention group as predicted and significantly greater reductions in the subgroup on oral medications only.

Distress levels at baseline and 12 months were among the study’s secondary outcomes, along with measures of medication adherence, self-efficacy, and self-care behaviors.

Dr. Cummings told the conference that the investigators were surprised to find “no substantial difference in the decline in distress levels between treatment groups. The folks in the intervention and control groups had fairly similar reductions in mean distress scores at 12 months,” he said, with two-thirds of subjects reporting some degree of decline.

The investigators combined data from the two groups to examine distress levels and other outcomes. “And we found that HbA_1c dropped much more substantially in those in whom distress was lowered, compared to those with whom distress was unchanged or increased,” Dr. Cummings said. “Medication adherence, self-care behaviors, and diabetes empowerment and self-efficacy were all substantially improved in the group with lower levels of distress at the end of the trial.”

But even after controlling for these other covariables, distress level remained a significant correlate of change in HbA_1c (P = .04).

“Why does this happen? The truth is, we don’t know,” Dr. Cummings said.

Changes in HbA_1c may be related to factors such as self-care behaviors and adherence, he acknowledged, “but quite frankly there could be other mechanisms less explored that may help to explain this relationship. So clearly we need additional research. What this does show is that lowering distress seems to be a valuable strategy in folks like this with elevated HbA_1c levels.”

Dr. Cummings spoke about some of the daily challenges facing the women in the study. “We’re surprised at the number of these women caring for children, grandchildren, and other members of their families, often while working, and yet not finding time to care for themselves. It is clearly an important cultural phenomenon that we need to understand better.”

Also at the conference, Dr. Cummings and colleagues presented a separate, striking set of findings on distress and cardiovascular outcomes using data from a different source: the national Reasons for Geographic And Racial Differences in Stroke (REGARDS) cohort study.

Dr. Cummings and colleagues compared the relationship between baseline depressive symptoms and/or distress and incident stroke, acute coronary heart disease (CHD), and CV death in more than 4,000 black and white adults 45 and older with diabetes, and nearly 18,000 subjects without diabetes, followed up for more than 5 years.

Subjects with diabetes were more likely to have either depressive symptoms or distress (26.7% vs. 23.2%, P < .001) or both (10.1% vs. 6.2%, P < .001), compared with those without diabetes.

In models adjusted for sociodemographics, medical conditions, health behaviors, and physiologic measures, either distress or depressive symptoms at baseline was associated with increased risk for stroke (adjusted hazard ratio 1.54; 95% confidence interval, 1.04-2.27) and cardiovascular (CV) death (aHR, 1.61; 95% CI, 1.14-2.29) among subjects with diabetes. None of these associations were significant for people without diabetes.

The presence of both depressive symptoms and distress at baseline was associated with an increased risk for acute CHD (aHR 1.58; 95% CI, 1-2.50) and CV death (aHR 2.27; 95% CI, 1.40-3.67) but not stroke (aHR 1.54; 95% CI, 0.84-2.82) in people with diabetes. However, this relationship was not observed in those without diabetes.

“Folks who reported diabetes plus stress and depressive symptoms had more than a twofold increase in CV death relative to those with diabetes with no behavioral comorbidity, even after adjusting for a wide range of demographic and CV risk factors,” Dr. Cummings told the conference.

“Comorbidity in patients with diabetes remains a challenging problem that is associated with increased risks,” he added.

The EMPOWER study was funded by the Bristol Myers Squibb Foundation. The REGARDS study was funded by the National Institutes of Health.

Dr. Cummings declared an advisory relationship with Sanofi-Aventis not bearing on either set of findings.

BOSTON – Rural African-American women with poorly controlled type 2 diabetes saw significant improvements in glycemic control when their disease-related distress levels dropped.

The findings, from a randomized, controlled trial of 150 women, add to a growing body of evidence that diabetes-related emotional distress – which can include concerns related to disease management, a fear of becoming sicker, and a sense of being isolated or overwhelmed as a result of the disease – bears on clinical outcomes in type 2 diabetes, particularly HbA_1c.

©Tashatuvango/Thinkstockphotos.com

A validated diabetes distress score was introduced a decade ago for use in clinical research (Diabetes Care 2005;28:626-31), and last year investigators in San Francisco showed that people with lower stress related to their diabetic care regimens had significantly lower HbA_1c and better medication adherence (Diabetes Care 2014;37:617-24).

At the annual scientific sessions of the American Diabetes Association, Doyle Cummings, Pharm.D., of East Carolina University in Greenville, N.C., presented data from the EMPOWER study, a prospective, randomized clinical trial among rural African-American women in North Carolina. Dr. Cummings reported a similar association between distress and HbA_1c.

The EMPOWER study randomized 150 mostly low-income African-American women with uncontrolled type 2 diabetes (mean age 55, mean 10.9 years with diabetes, and mean HbA_1c of 9.1) to an in-person or phone-delivered lifestyle intervention delivered by community health workers or mailed written advice. The in-person or phone-delivered intervention involved 16 sessions of training in nutrition, physical activity, and self-monitoring, emphasizing small and incremental changes.

The investigators looked at weight and HbA_1c at 12 months, compared with baseline in both groups, and found modest improvements for both measures in the active intervention group as predicted and significantly greater reductions in the subgroup on oral medications only.

Distress levels at baseline and 12 months were among the study’s secondary outcomes, along with measures of medication adherence, self-efficacy, and self-care behaviors.

Dr. Cummings told the conference that the investigators were surprised to find “no substantial difference in the decline in distress levels between treatment groups. The folks in the intervention and control groups had fairly similar reductions in mean distress scores at 12 months,” he said, with two-thirds of subjects reporting some degree of decline.

The investigators combined data from the two groups to examine distress levels and other outcomes. “And we found that HbA_1c dropped much more substantially in those in whom distress was lowered, compared to those with whom distress was unchanged or increased,” Dr. Cummings said. “Medication adherence, self-care behaviors, and diabetes empowerment and self-efficacy were all substantially improved in the group with lower levels of distress at the end of the trial.”

But even after controlling for these other covariables, distress level remained a significant correlate of change in HbA_1c (P = .04).

“Why does this happen? The truth is, we don’t know,” Dr. Cummings said.

Changes in HbA_1c may be related to factors such as self-care behaviors and adherence, he acknowledged, “but quite frankly there could be other mechanisms less explored that may help to explain this relationship. So clearly we need additional research. What this does show is that lowering distress seems to be a valuable strategy in folks like this with elevated HbA_1c levels.”

Dr. Cummings spoke about some of the daily challenges facing the women in the study. “We’re surprised at the number of these women caring for children, grandchildren, and other members of their families, often while working, and yet not finding time to care for themselves. It is clearly an important cultural phenomenon that we need to understand better.”

Also at the conference, Dr. Cummings and colleagues presented a separate, striking set of findings on distress and cardiovascular outcomes using data from a different source: the national Reasons for Geographic And Racial Differences in Stroke (REGARDS) cohort study.

Dr. Cummings and colleagues compared the relationship between baseline depressive symptoms and/or distress and incident stroke, acute coronary heart disease (CHD), and CV death in more than 4,000 black and white adults 45 and older with diabetes, and nearly 18,000 subjects without diabetes, followed up for more than 5 years.

Subjects with diabetes were more likely to have either depressive symptoms or distress (26.7% vs. 23.2%, P < .001) or both (10.1% vs. 6.2%, P < .001), compared with those without diabetes.

In models adjusted for sociodemographics, medical conditions, health behaviors, and physiologic measures, either distress or depressive symptoms at baseline was associated with increased risk for stroke (adjusted hazard ratio 1.54; 95% confidence interval, 1.04-2.27) and cardiovascular (CV) death (aHR, 1.61; 95% CI, 1.14-2.29) among subjects with diabetes. None of these associations were significant for people without diabetes.

The presence of both depressive symptoms and distress at baseline was associated with an increased risk for acute CHD (aHR 1.58; 95% CI, 1-2.50) and CV death (aHR 2.27; 95% CI, 1.40-3.67) but not stroke (aHR 1.54; 95% CI, 0.84-2.82) in people with diabetes. However, this relationship was not observed in those without diabetes.

“Folks who reported diabetes plus stress and depressive symptoms had more than a twofold increase in CV death relative to those with diabetes with no behavioral comorbidity, even after adjusting for a wide range of demographic and CV risk factors,” Dr. Cummings told the conference.

“Comorbidity in patients with diabetes remains a challenging problem that is associated with increased risks,” he added.

The EMPOWER study was funded by the Bristol Myers Squibb Foundation. The REGARDS study was funded by the National Institutes of Health.

Dr. Cummings declared an advisory relationship with Sanofi-Aventis not bearing on either set of findings.

BOSTON – Rural African-American women with poorly controlled type 2 diabetes saw significant improvements in glycemic control when their disease-related distress levels dropped.

The findings, from a randomized, controlled trial of 150 women, add to a growing body of evidence that diabetes-related emotional distress – which can include concerns related to disease management, a fear of becoming sicker, and a sense of being isolated or overwhelmed as a result of the disease – bears on clinical outcomes in type 2 diabetes, particularly HbA_1c.

©Tashatuvango/Thinkstockphotos.com

A validated diabetes distress score was introduced a decade ago for use in clinical research (Diabetes Care 2005;28:626-31), and last year investigators in San Francisco showed that people with lower stress related to their diabetic care regimens had significantly lower HbA_1c and better medication adherence (Diabetes Care 2014;37:617-24).

At the annual scientific sessions of the American Diabetes Association, Doyle Cummings, Pharm.D., of East Carolina University in Greenville, N.C., presented data from the EMPOWER study, a prospective, randomized clinical trial among rural African-American women in North Carolina. Dr. Cummings reported a similar association between distress and HbA_1c.

The EMPOWER study randomized 150 mostly low-income African-American women with uncontrolled type 2 diabetes (mean age 55, mean 10.9 years with diabetes, and mean HbA_1c of 9.1) to an in-person or phone-delivered lifestyle intervention delivered by community health workers or mailed written advice. The in-person or phone-delivered intervention involved 16 sessions of training in nutrition, physical activity, and self-monitoring, emphasizing small and incremental changes.

The investigators looked at weight and HbA_1c at 12 months, compared with baseline in both groups, and found modest improvements for both measures in the active intervention group as predicted and significantly greater reductions in the subgroup on oral medications only.

Distress levels at baseline and 12 months were among the study’s secondary outcomes, along with measures of medication adherence, self-efficacy, and self-care behaviors.

Dr. Cummings told the conference that the investigators were surprised to find “no substantial difference in the decline in distress levels between treatment groups. The folks in the intervention and control groups had fairly similar reductions in mean distress scores at 12 months,” he said, with two-thirds of subjects reporting some degree of decline.

The investigators combined data from the two groups to examine distress levels and other outcomes. “And we found that HbA_1c dropped much more substantially in those in whom distress was lowered, compared to those with whom distress was unchanged or increased,” Dr. Cummings said. “Medication adherence, self-care behaviors, and diabetes empowerment and self-efficacy were all substantially improved in the group with lower levels of distress at the end of the trial.”

But even after controlling for these other covariables, distress level remained a significant correlate of change in HbA_1c (P = .04).

“Why does this happen? The truth is, we don’t know,” Dr. Cummings said.

Changes in HbA_1c may be related to factors such as self-care behaviors and adherence, he acknowledged, “but quite frankly there could be other mechanisms less explored that may help to explain this relationship. So clearly we need additional research. What this does show is that lowering distress seems to be a valuable strategy in folks like this with elevated HbA_1c levels.”

Dr. Cummings spoke about some of the daily challenges facing the women in the study. “We’re surprised at the number of these women caring for children, grandchildren, and other members of their families, often while working, and yet not finding time to care for themselves. It is clearly an important cultural phenomenon that we need to understand better.”

Also at the conference, Dr. Cummings and colleagues presented a separate, striking set of findings on distress and cardiovascular outcomes using data from a different source: the national Reasons for Geographic And Racial Differences in Stroke (REGARDS) cohort study.

Dr. Cummings and colleagues compared the relationship between baseline depressive symptoms and/or distress and incident stroke, acute coronary heart disease (CHD), and CV death in more than 4,000 black and white adults 45 and older with diabetes, and nearly 18,000 subjects without diabetes, followed up for more than 5 years.

Subjects with diabetes were more likely to have either depressive symptoms or distress (26.7% vs. 23.2%, P < .001) or both (10.1% vs. 6.2%, P < .001), compared with those without diabetes.

In models adjusted for sociodemographics, medical conditions, health behaviors, and physiologic measures, either distress or depressive symptoms at baseline was associated with increased risk for stroke (adjusted hazard ratio 1.54; 95% confidence interval, 1.04-2.27) and cardiovascular (CV) death (aHR, 1.61; 95% CI, 1.14-2.29) among subjects with diabetes. None of these associations were significant for people without diabetes.

The presence of both depressive symptoms and distress at baseline was associated with an increased risk for acute CHD (aHR 1.58; 95% CI, 1-2.50) and CV death (aHR 2.27; 95% CI, 1.40-3.67) but not stroke (aHR 1.54; 95% CI, 0.84-2.82) in people with diabetes. However, this relationship was not observed in those without diabetes.

“Folks who reported diabetes plus stress and depressive symptoms had more than a twofold increase in CV death relative to those with diabetes with no behavioral comorbidity, even after adjusting for a wide range of demographic and CV risk factors,” Dr. Cummings told the conference.

“Comorbidity in patients with diabetes remains a challenging problem that is associated with increased risks,” he added.

The EMPOWER study was funded by the Bristol Myers Squibb Foundation. The REGARDS study was funded by the National Institutes of Health.

Dr. Cummings declared an advisory relationship with Sanofi-Aventis not bearing on either set of findings.

BOSTON – Diabetes leads to a loss of 2.3-6.8 life-years and costs between $14,768 and $159,081 over a lifetime, depending on age, sex, race, and body mass index, according to National Health Interview Survey (NHIS) and Medical Expenditure Panel Survey (MEPS) data.

The average number of life-years lost was greater for women than for men, and was greater for blacks than for whites (average of 5.2 for black women vs. 5.0 years for white women, and 4.8 for black men vs. 4.6 for white men). Life-years lost increased with BMI category for most of the age-sex-race combinations evaluated, Man Yee (Mallory) Leung, Ph.D., reported at the annual scientific sessions of the American Diabetes Association. The lifetime costs were higher for men than for women ($93,957 vs. $81,521), and an inverted U-shape was noted across BMI categories for most of the age/sex/race groups, with peaks at the Class II obesity category, said Dr. Leung of Washington University, St. Louis.

Dr. Leung and her colleagues used data from the 2009-2012 NHIS (the most recently available data), and linked to the Medical Expenditure Panel Survey for their analysis. The NHIS Linked Mortality Public-Use Files were used to predict mortality risk.

The sample was divided into groups with different combinations of race, sex, age, and BMI categories, and life expectancies and lifetime health care expenditures for diabetic patients and nondiabetic patients were simulated, she explained, noting that all estimates were adjusted for complex sampling design in the NHIS and MEPS.

The findings underscore the huge economic burden of diabetes on society, and further define the associated life years lost as a result of the disease, she said.

This study was supported by the Agency for Healthcare Research and Quality and the National Institutes of Health, as well as by grants to one of the authors from the Foundation for Barnes-Jewish Hospital and the Breast Cancer Research Foundation. Dr. Leung reported having no conflicts of interest.

[email protected]

BOSTON – Diabetes leads to a loss of 2.3-6.8 life-years and costs between $14,768 and $159,081 over a lifetime, depending on age, sex, race, and body mass index, according to National Health Interview Survey (NHIS) and Medical Expenditure Panel Survey (MEPS) data.

The average number of life-years lost was greater for women than for men, and was greater for blacks than for whites (average of 5.2 for black women vs. 5.0 years for white women, and 4.8 for black men vs. 4.6 for white men). Life-years lost increased with BMI category for most of the age-sex-race combinations evaluated, Man Yee (Mallory) Leung, Ph.D., reported at the annual scientific sessions of the American Diabetes Association. The lifetime costs were higher for men than for women ($93,957 vs. $81,521), and an inverted U-shape was noted across BMI categories for most of the age/sex/race groups, with peaks at the Class II obesity category, said Dr. Leung of Washington University, St. Louis.

Dr. Leung and her colleagues used data from the 2009-2012 NHIS (the most recently available data), and linked to the Medical Expenditure Panel Survey for their analysis. The NHIS Linked Mortality Public-Use Files were used to predict mortality risk.

The sample was divided into groups with different combinations of race, sex, age, and BMI categories, and life expectancies and lifetime health care expenditures for diabetic patients and nondiabetic patients were simulated, she explained, noting that all estimates were adjusted for complex sampling design in the NHIS and MEPS.

The findings underscore the huge economic burden of diabetes on society, and further define the associated life years lost as a result of the disease, she said.

This study was supported by the Agency for Healthcare Research and Quality and the National Institutes of Health, as well as by grants to one of the authors from the Foundation for Barnes-Jewish Hospital and the Breast Cancer Research Foundation. Dr. Leung reported having no conflicts of interest.

[email protected]

BOSTON – Diabetes leads to a loss of 2.3-6.8 life-years and costs between $14,768 and $159,081 over a lifetime, depending on age, sex, race, and body mass index, according to National Health Interview Survey (NHIS) and Medical Expenditure Panel Survey (MEPS) data.

The average number of life-years lost was greater for women than for men, and was greater for blacks than for whites (average of 5.2 for black women vs. 5.0 years for white women, and 4.8 for black men vs. 4.6 for white men). Life-years lost increased with BMI category for most of the age-sex-race combinations evaluated, Man Yee (Mallory) Leung, Ph.D., reported at the annual scientific sessions of the American Diabetes Association. The lifetime costs were higher for men than for women ($93,957 vs. $81,521), and an inverted U-shape was noted across BMI categories for most of the age/sex/race groups, with peaks at the Class II obesity category, said Dr. Leung of Washington University, St. Louis.

Dr. Leung and her colleagues used data from the 2009-2012 NHIS (the most recently available data), and linked to the Medical Expenditure Panel Survey for their analysis. The NHIS Linked Mortality Public-Use Files were used to predict mortality risk.

The sample was divided into groups with different combinations of race, sex, age, and BMI categories, and life expectancies and lifetime health care expenditures for diabetic patients and nondiabetic patients were simulated, she explained, noting that all estimates were adjusted for complex sampling design in the NHIS and MEPS.

The findings underscore the huge economic burden of diabetes on society, and further define the associated life years lost as a result of the disease, she said.

This study was supported by the Agency for Healthcare Research and Quality and the National Institutes of Health, as well as by grants to one of the authors from the Foundation for Barnes-Jewish Hospital and the Breast Cancer Research Foundation. Dr. Leung reported having no conflicts of interest.

[email protected]

The St. Jude Lifetime Cohort study found obesity in a higher percentage of adult survivors of childhood cancer than previous studies.

Thirty-six percent of the research project’s 1,996 participants were obese, which the study defined as having a body mass index (BMI) of greater than or equal to 30 kg/m². All of the study’s participants previously had received treatment for cancer at St. Jude Children’s Research Hospital, Memphis, Tenn., and had been cancer survivors for at least 10 years.

The prevalence of obesity was even higher in the subset of the sample that had been treated with cranial radiation (CRT). Forty-five percent of such survivors were obese, compared to 29.4% of the study’s participants, who had not been exposed to CRT. Another finding specific to the cancer survivors that had received CRT were associations between obesity, and variations in the regions in and around the genes FAM155A, GLRA3, CDH18, and SOX11.

“Because both CDH18 and SOX11 appear to influence neuronal growth, repair, and connectivity, these genes may be important regulators of neuronal response to radiation-induced damage among CCS,” according to Carmen L. Wilson, Ph.D., and her colleagues. They added that single nucleotide polymorphisms in such genes could alter obesity risk but said more research needs to be conducted to confirm this.

Among the study’s other findings were that older age at evaluation, previous treatment with CRT, and glucocorticoid exposures were independently associated with obesity. Chest, abdominal, or pelvic, radiation exposure, in contrast, were negatively correlated with having a BMI at or above 30 kg/m².

The study has confirmed that “the high prevalence of obesity among [survivors of childhood cancer] persists decades after cancer treatment and appears to be influenced by therapies received during childhood and obesity status at diagnosis,” according to the researchers.

Read the full study in Cancer (doi: 10.10002/cncr.29153).

The St. Jude Lifetime Cohort study found obesity in a higher percentage of adult survivors of childhood cancer than previous studies.

Thirty-six percent of the research project’s 1,996 participants were obese, which the study defined as having a body mass index (BMI) of greater than or equal to 30 kg/m². All of the study’s participants previously had received treatment for cancer at St. Jude Children’s Research Hospital, Memphis, Tenn., and had been cancer survivors for at least 10 years.

The prevalence of obesity was even higher in the subset of the sample that had been treated with cranial radiation (CRT). Forty-five percent of such survivors were obese, compared to 29.4% of the study’s participants, who had not been exposed to CRT. Another finding specific to the cancer survivors that had received CRT were associations between obesity, and variations in the regions in and around the genes FAM155A, GLRA3, CDH18, and SOX11.

“Because both CDH18 and SOX11 appear to influence neuronal growth, repair, and connectivity, these genes may be important regulators of neuronal response to radiation-induced damage among CCS,” according to Carmen L. Wilson, Ph.D., and her colleagues. They added that single nucleotide polymorphisms in such genes could alter obesity risk but said more research needs to be conducted to confirm this.

Among the study’s other findings were that older age at evaluation, previous treatment with CRT, and glucocorticoid exposures were independently associated with obesity. Chest, abdominal, or pelvic, radiation exposure, in contrast, were negatively correlated with having a BMI at or above 30 kg/m².

The study has confirmed that “the high prevalence of obesity among [survivors of childhood cancer] persists decades after cancer treatment and appears to be influenced by therapies received during childhood and obesity status at diagnosis,” according to the researchers.

Read the full study in Cancer (doi: 10.10002/cncr.29153).

The St. Jude Lifetime Cohort study found obesity in a higher percentage of adult survivors of childhood cancer than previous studies.

Thirty-six percent of the research project’s 1,996 participants were obese, which the study defined as having a body mass index (BMI) of greater than or equal to 30 kg/m². All of the study’s participants previously had received treatment for cancer at St. Jude Children’s Research Hospital, Memphis, Tenn., and had been cancer survivors for at least 10 years.

The prevalence of obesity was even higher in the subset of the sample that had been treated with cranial radiation (CRT). Forty-five percent of such survivors were obese, compared to 29.4% of the study’s participants, who had not been exposed to CRT. Another finding specific to the cancer survivors that had received CRT were associations between obesity, and variations in the regions in and around the genes FAM155A, GLRA3, CDH18, and SOX11.

“Because both CDH18 and SOX11 appear to influence neuronal growth, repair, and connectivity, these genes may be important regulators of neuronal response to radiation-induced damage among CCS,” according to Carmen L. Wilson, Ph.D., and her colleagues. They added that single nucleotide polymorphisms in such genes could alter obesity risk but said more research needs to be conducted to confirm this.

Among the study’s other findings were that older age at evaluation, previous treatment with CRT, and glucocorticoid exposures were independently associated with obesity. Chest, abdominal, or pelvic, radiation exposure, in contrast, were negatively correlated with having a BMI at or above 30 kg/m².

The study has confirmed that “the high prevalence of obesity among [survivors of childhood cancer] persists decades after cancer treatment and appears to be influenced by therapies received during childhood and obesity status at diagnosis,” according to the researchers.

Read the full study in Cancer (doi: 10.10002/cncr.29153).