Obesity

Tirzepatide (Zepbound) is not in shortage for now, but the weight loss drug has remained inaccessible to people without insurance coverage who can’t afford to pay out of pocket. Now, its manufacturer, Eli Lilly, has introduced a new formulation it says will “significantly expand” the supply. But not all endocrinologists are enthusiastic.

As of August 27, LillyDirect made 2.5-mg and 5-mg single-dose vials of tirzepatide available to self-pay patients with an on-label electronic prescription. Lilly’s announcement said the single-dose vials “are priced at a 50% or greater discount compared to the list price of all other incretin (glucagon-like peptide 1 receptor agonists or GLP-1) medicines for obesity.”

For a 4-week supply of the weekly injections, the discount at LillyDirect translates to $399 for a 2.5-mg single-dose vial ($99.75 per vial) and $549 for the 5-mg dose ($137.25 per vial), which the company noted was “in line with the Zepbound savings program for noncovered individuals.” (The new direct single-dose prescriptions cannot be filled at community or retail pharmacies.)

“In a clinical study, the 5-mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off,” according to the announcement.

The clinical study, which is not named or referenced in the announcement, is SURMOUNT-1, a Lilly spokesperson said in an interview. Yet, that study also found that patients achieved an average weight loss of 19.5% with 10-mg doses and 20.9% with 15-mg doses of tirzepatide. Furthermore, the percentage of participants achieving body weight reductions of ≥ 5% was 85% (5 mg), 89% (10 mg), and 91% (15 mg), showing the benefits of higher doses.

And there’s the rub.
 

‘Only Two Different Doses’

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the University of Southern California, Los Angeles, said in an interview: “My concern is, they’re only providing two different doses, 2.5 mg and 5 mg. You get somebody on it, and then they still have to go back to the traditional pens. I’m very opposed to getting patients connected to a medication they can’t then continue to take.

“Now we have starter doses that are easy to come by,” she said. “But the problem isn’t starting. The problem for all of these patients is chronic continuation of the right dose of the drug, and out-of-pocket costs become exorbitantly higher when they have to self-purchase the pens for the higher doses.

“Yes, the 5-mg dose has benefits, but not the same as higher doses,” she continued. “I have nobody for whom 5 mg is the right dose. They have to take more, sometimes within a month or 2 of starting, in order to achieve the kind of weight loss they need.”

If their insurance doesn’t cover the drug, “what are they going to do to stay on 5 mg? Or pay a crapload of money to buy three of the 5-mg doses to reach a higher dose?”

Michael Weintraub, MD, clinical assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism at New York University Grossman School of Medicine in New York City, said that, “for many, this lower monthly cost is attainable and is a significant advancement in increasing access. For others, however, an out-of-pocket monthly cost of $349-549 for a chronic medication is still unaffordable.”

And like Dr. Peters, he said, “some patients do not lose a clinically significant amount of weight with 2.5 mg or 5 mg and require higher doses. There is no way of prescribing a higher dose of Zepbound vials, so patients would have to resort to the higher-dose auto-injector pens that are still double the price.”

A Lilly spokesperson countered in a comment: “Offering Zepbound single-dose vials in higher dosage strengths could increase the potential for dose splitting, which is not contemplated by the FDA [Food and Drug Adminstration]–approved label and may pose patient safety risks.”

But Dr. Peters wondered: “Wouldn’t dose splitting of a known-to-be-pure compound be better than getting it at a compounding pharmacy that lacks purity/safety? The one message from all of this is that patients need to know what they’re getting into. They’re starting a drug that can help with weight loss, but they’re going to be on a sub-max dose. And a higher dose is going to be double the price.”

In addition, said Robert F. Kushner, MD, a professor at Northwestern University Feinberg School of Medicine in Chicago, Illinois, “for the lower-dose vials, instead of administering the drug with a self-auto-injection pen, patients will need to use a needle and syringe and draw up the dose from a vial. This will take a higher skill level and health literacy that may be challenging for some patients. Patients may need additional training on how to use this new formulation. That will take additional time and resources, such as a demonstration in the office or referral to video.”

The Lilly news release noted that “patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.”
 

Protection From Compounders?

According to the Lilly spokesperson, the launch of Zepbound vials “furthers our commitment to helping patients avoid the risks associated with compounded products by providing patients another option for access to genuine Lilly medicine.”

Indeed, said Jaime Almandoz, MD, medical director of the Weight Wellness Program and associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, “The introduction of Zepbound/tirzepatide in single-dose vials should improve access to evidence-based obesity treatments, reducing potential risks associated with compounded additives and eliminating the need for patients to calculate correct medication doses,” which have led to accidental overdoses of compounded semaglutide.

Lilly’s spokesperson added: “We have taken multiple steps — including publishing an open letter and launching lilly.com/real-medicine — to warn the public about the risks posed by the proliferation of counterfeit, fake, unsafe, or untested knockoffs of Lilly’s genuine medicines.”

But whether these steps are strong enough to overcome the realities of cost and the need for affordable higher doses remains to be seen.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement that the new version of Zepbound “is great news for patients. It’s a much more rational and care-focused response to the remarkable demand for their drug than the lawsuits and cease-and-desist letters Lilly has been raining down on compounding pharmacies.”

“For 20 months now,” he continued, “compounders have been a lifeline for many patients, filling prescriptions for compounded tirzepatide injection at a time when the FDA-approved drug has been in shortage. We’ll be eager to see whether Lilly’s direct-to-patient approach actually works.”

Dr. Almandoz affirmed: “Everyone wants to see improved access to evidence-based obesity care. It’s crucial to ensure patients receive the most appropriate interventions, whether it is lifestyle changes, medications, or bariatric surgery,” he said. “There are resources available, [including his recent paper], for nutrition and lifestyle modifications specifically for patients taking obesity medications, which can help clinicians guide their patients toward better health.”

Dr. Almandoz is a member of advisory boards and consults for: Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. Dr. Kushner is an adviser to Eli Lilly and Novo Nordisk. Dr. Peters and Dr. Weintraub declared no competing interests.

A version of this article appeared on Medscape.com.

Tirzepatide (Zepbound) is not in shortage for now, but the weight loss drug has remained inaccessible to people without insurance coverage who can’t afford to pay out of pocket. Now, its manufacturer, Eli Lilly, has introduced a new formulation it says will “significantly expand” the supply. But not all endocrinologists are enthusiastic.

As of August 27, LillyDirect made 2.5-mg and 5-mg single-dose vials of tirzepatide available to self-pay patients with an on-label electronic prescription. Lilly’s announcement said the single-dose vials “are priced at a 50% or greater discount compared to the list price of all other incretin (glucagon-like peptide 1 receptor agonists or GLP-1) medicines for obesity.”

For a 4-week supply of the weekly injections, the discount at LillyDirect translates to $399 for a 2.5-mg single-dose vial ($99.75 per vial) and $549 for the 5-mg dose ($137.25 per vial), which the company noted was “in line with the Zepbound savings program for noncovered individuals.” (The new direct single-dose prescriptions cannot be filled at community or retail pharmacies.)

“In a clinical study, the 5-mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off,” according to the announcement.

The clinical study, which is not named or referenced in the announcement, is SURMOUNT-1, a Lilly spokesperson said in an interview. Yet, that study also found that patients achieved an average weight loss of 19.5% with 10-mg doses and 20.9% with 15-mg doses of tirzepatide. Furthermore, the percentage of participants achieving body weight reductions of ≥ 5% was 85% (5 mg), 89% (10 mg), and 91% (15 mg), showing the benefits of higher doses.

And there’s the rub.
 

‘Only Two Different Doses’

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the University of Southern California, Los Angeles, said in an interview: “My concern is, they’re only providing two different doses, 2.5 mg and 5 mg. You get somebody on it, and then they still have to go back to the traditional pens. I’m very opposed to getting patients connected to a medication they can’t then continue to take.

“Now we have starter doses that are easy to come by,” she said. “But the problem isn’t starting. The problem for all of these patients is chronic continuation of the right dose of the drug, and out-of-pocket costs become exorbitantly higher when they have to self-purchase the pens for the higher doses.

“Yes, the 5-mg dose has benefits, but not the same as higher doses,” she continued. “I have nobody for whom 5 mg is the right dose. They have to take more, sometimes within a month or 2 of starting, in order to achieve the kind of weight loss they need.”

If their insurance doesn’t cover the drug, “what are they going to do to stay on 5 mg? Or pay a crapload of money to buy three of the 5-mg doses to reach a higher dose?”

Michael Weintraub, MD, clinical assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism at New York University Grossman School of Medicine in New York City, said that, “for many, this lower monthly cost is attainable and is a significant advancement in increasing access. For others, however, an out-of-pocket monthly cost of $349-549 for a chronic medication is still unaffordable.”

And like Dr. Peters, he said, “some patients do not lose a clinically significant amount of weight with 2.5 mg or 5 mg and require higher doses. There is no way of prescribing a higher dose of Zepbound vials, so patients would have to resort to the higher-dose auto-injector pens that are still double the price.”

A Lilly spokesperson countered in a comment: “Offering Zepbound single-dose vials in higher dosage strengths could increase the potential for dose splitting, which is not contemplated by the FDA [Food and Drug Adminstration]–approved label and may pose patient safety risks.”

But Dr. Peters wondered: “Wouldn’t dose splitting of a known-to-be-pure compound be better than getting it at a compounding pharmacy that lacks purity/safety? The one message from all of this is that patients need to know what they’re getting into. They’re starting a drug that can help with weight loss, but they’re going to be on a sub-max dose. And a higher dose is going to be double the price.”

In addition, said Robert F. Kushner, MD, a professor at Northwestern University Feinberg School of Medicine in Chicago, Illinois, “for the lower-dose vials, instead of administering the drug with a self-auto-injection pen, patients will need to use a needle and syringe and draw up the dose from a vial. This will take a higher skill level and health literacy that may be challenging for some patients. Patients may need additional training on how to use this new formulation. That will take additional time and resources, such as a demonstration in the office or referral to video.”

The Lilly news release noted that “patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.”
 

Protection From Compounders?

According to the Lilly spokesperson, the launch of Zepbound vials “furthers our commitment to helping patients avoid the risks associated with compounded products by providing patients another option for access to genuine Lilly medicine.”

Indeed, said Jaime Almandoz, MD, medical director of the Weight Wellness Program and associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, “The introduction of Zepbound/tirzepatide in single-dose vials should improve access to evidence-based obesity treatments, reducing potential risks associated with compounded additives and eliminating the need for patients to calculate correct medication doses,” which have led to accidental overdoses of compounded semaglutide.

Lilly’s spokesperson added: “We have taken multiple steps — including publishing an open letter and launching lilly.com/real-medicine — to warn the public about the risks posed by the proliferation of counterfeit, fake, unsafe, or untested knockoffs of Lilly’s genuine medicines.”

But whether these steps are strong enough to overcome the realities of cost and the need for affordable higher doses remains to be seen.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement that the new version of Zepbound “is great news for patients. It’s a much more rational and care-focused response to the remarkable demand for their drug than the lawsuits and cease-and-desist letters Lilly has been raining down on compounding pharmacies.”

“For 20 months now,” he continued, “compounders have been a lifeline for many patients, filling prescriptions for compounded tirzepatide injection at a time when the FDA-approved drug has been in shortage. We’ll be eager to see whether Lilly’s direct-to-patient approach actually works.”

Dr. Almandoz affirmed: “Everyone wants to see improved access to evidence-based obesity care. It’s crucial to ensure patients receive the most appropriate interventions, whether it is lifestyle changes, medications, or bariatric surgery,” he said. “There are resources available, [including his recent paper], for nutrition and lifestyle modifications specifically for patients taking obesity medications, which can help clinicians guide their patients toward better health.”

Dr. Almandoz is a member of advisory boards and consults for: Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. Dr. Kushner is an adviser to Eli Lilly and Novo Nordisk. Dr. Peters and Dr. Weintraub declared no competing interests.

A version of this article appeared on Medscape.com.

Tirzepatide (Zepbound) is not in shortage for now, but the weight loss drug has remained inaccessible to people without insurance coverage who can’t afford to pay out of pocket. Now, its manufacturer, Eli Lilly, has introduced a new formulation it says will “significantly expand” the supply. But not all endocrinologists are enthusiastic.

As of August 27, LillyDirect made 2.5-mg and 5-mg single-dose vials of tirzepatide available to self-pay patients with an on-label electronic prescription. Lilly’s announcement said the single-dose vials “are priced at a 50% or greater discount compared to the list price of all other incretin (glucagon-like peptide 1 receptor agonists or GLP-1) medicines for obesity.”

For a 4-week supply of the weekly injections, the discount at LillyDirect translates to $399 for a 2.5-mg single-dose vial ($99.75 per vial) and $549 for the 5-mg dose ($137.25 per vial), which the company noted was “in line with the Zepbound savings program for noncovered individuals.” (The new direct single-dose prescriptions cannot be filled at community or retail pharmacies.)

“In a clinical study, the 5-mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off,” according to the announcement.

The clinical study, which is not named or referenced in the announcement, is SURMOUNT-1, a Lilly spokesperson said in an interview. Yet, that study also found that patients achieved an average weight loss of 19.5% with 10-mg doses and 20.9% with 15-mg doses of tirzepatide. Furthermore, the percentage of participants achieving body weight reductions of ≥ 5% was 85% (5 mg), 89% (10 mg), and 91% (15 mg), showing the benefits of higher doses.

And there’s the rub.
 

‘Only Two Different Doses’

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the University of Southern California, Los Angeles, said in an interview: “My concern is, they’re only providing two different doses, 2.5 mg and 5 mg. You get somebody on it, and then they still have to go back to the traditional pens. I’m very opposed to getting patients connected to a medication they can’t then continue to take.

“Now we have starter doses that are easy to come by,” she said. “But the problem isn’t starting. The problem for all of these patients is chronic continuation of the right dose of the drug, and out-of-pocket costs become exorbitantly higher when they have to self-purchase the pens for the higher doses.

“Yes, the 5-mg dose has benefits, but not the same as higher doses,” she continued. “I have nobody for whom 5 mg is the right dose. They have to take more, sometimes within a month or 2 of starting, in order to achieve the kind of weight loss they need.”

If their insurance doesn’t cover the drug, “what are they going to do to stay on 5 mg? Or pay a crapload of money to buy three of the 5-mg doses to reach a higher dose?”

Michael Weintraub, MD, clinical assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism at New York University Grossman School of Medicine in New York City, said that, “for many, this lower monthly cost is attainable and is a significant advancement in increasing access. For others, however, an out-of-pocket monthly cost of $349-549 for a chronic medication is still unaffordable.”

And like Dr. Peters, he said, “some patients do not lose a clinically significant amount of weight with 2.5 mg or 5 mg and require higher doses. There is no way of prescribing a higher dose of Zepbound vials, so patients would have to resort to the higher-dose auto-injector pens that are still double the price.”

A Lilly spokesperson countered in a comment: “Offering Zepbound single-dose vials in higher dosage strengths could increase the potential for dose splitting, which is not contemplated by the FDA [Food and Drug Adminstration]–approved label and may pose patient safety risks.”

But Dr. Peters wondered: “Wouldn’t dose splitting of a known-to-be-pure compound be better than getting it at a compounding pharmacy that lacks purity/safety? The one message from all of this is that patients need to know what they’re getting into. They’re starting a drug that can help with weight loss, but they’re going to be on a sub-max dose. And a higher dose is going to be double the price.”

In addition, said Robert F. Kushner, MD, a professor at Northwestern University Feinberg School of Medicine in Chicago, Illinois, “for the lower-dose vials, instead of administering the drug with a self-auto-injection pen, patients will need to use a needle and syringe and draw up the dose from a vial. This will take a higher skill level and health literacy that may be challenging for some patients. Patients may need additional training on how to use this new formulation. That will take additional time and resources, such as a demonstration in the office or referral to video.”

The Lilly news release noted that “patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.”
 

Protection From Compounders?

According to the Lilly spokesperson, the launch of Zepbound vials “furthers our commitment to helping patients avoid the risks associated with compounded products by providing patients another option for access to genuine Lilly medicine.”

Indeed, said Jaime Almandoz, MD, medical director of the Weight Wellness Program and associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, “The introduction of Zepbound/tirzepatide in single-dose vials should improve access to evidence-based obesity treatments, reducing potential risks associated with compounded additives and eliminating the need for patients to calculate correct medication doses,” which have led to accidental overdoses of compounded semaglutide.

Lilly’s spokesperson added: “We have taken multiple steps — including publishing an open letter and launching lilly.com/real-medicine — to warn the public about the risks posed by the proliferation of counterfeit, fake, unsafe, or untested knockoffs of Lilly’s genuine medicines.”

But whether these steps are strong enough to overcome the realities of cost and the need for affordable higher doses remains to be seen.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement that the new version of Zepbound “is great news for patients. It’s a much more rational and care-focused response to the remarkable demand for their drug than the lawsuits and cease-and-desist letters Lilly has been raining down on compounding pharmacies.”

“For 20 months now,” he continued, “compounders have been a lifeline for many patients, filling prescriptions for compounded tirzepatide injection at a time when the FDA-approved drug has been in shortage. We’ll be eager to see whether Lilly’s direct-to-patient approach actually works.”

Dr. Almandoz affirmed: “Everyone wants to see improved access to evidence-based obesity care. It’s crucial to ensure patients receive the most appropriate interventions, whether it is lifestyle changes, medications, or bariatric surgery,” he said. “There are resources available, [including his recent paper], for nutrition and lifestyle modifications specifically for patients taking obesity medications, which can help clinicians guide their patients toward better health.”

Dr. Almandoz is a member of advisory boards and consults for: Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. Dr. Kushner is an adviser to Eli Lilly and Novo Nordisk. Dr. Peters and Dr. Weintraub declared no competing interests.

A version of this article appeared on Medscape.com.

In the setting of isocaloric eating, time-restricted eating (TRE) did not reduce weight or improve glucose homeostasis relative to a usual eating pattern (UEP), a small randomized controlled trial found.

The results suggested that any effects of TRE on weight observed in prior studies may be due to reductions in caloric intake and not timing, according to Nisa M. Maruthur, MD, MHS, of the Division of General Internal Medicine at the Johns Hopkins School of Medicine in Baltimore, and colleagues.

Published in Annals of Internal Medicine, the 12-week trial randomly assigned 41 adults aged 18-69 years with obesity and prediabetes or diet-controlled diabetes 1:1 as follows: To TRE, involving a 10-hour eating window with 80% of calories consumed before 1 PM, or to UEP, involving a ≤ 16-hour window, with at least 50% of calories consumed after 5 PM. The regimen in each group was based on the OmniHeart unsaturated fat diet and the SPICE study.

“The diet was similar to the DASH [Dietary Approaches to Stop Hypertension] diet for hypertension and maybe a bit higher in unsaturated fat and micronutrients,” said study co-author Scott J. Pilla, MD, MHS, an assistant professor of medicine at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. For each participant, macro- and micronutrient content remained constant throughout the study period, with total calories individually determined at baseline and ranging from 1600 to 3500 kcal/d. “That differs from some TRE studies in which calories were adjusted according to whether participants lost or gained weight,” he said. “This was a purely mechanistic study to determine the impact of time of eating alone with no change in calories.”

The Cohort

The mean age was 59 years, 93% of patients were women, and 93% were Black. The mean body mass index was 36, and the mean baseline weight was 96.2 kg — 95.6 kg in the TRE group and 103.7 kg in the UEP group.

At 12 weeks, weight decreased comparably by 2.3 kg (95% CI, 1.0-3.5) in the TRE group and by 2.6 kg (95% CI, 1.5-3.7) in the UEP group. Change in glycemic measures did not differ between the two groups.

Interestingly, self-reporting questionnaires revealed a slight reduction in physical activity in the TRE group, an effect that requires further study. “We don’t know why but anecdotally, some TRE participants said they tended to go to bed earlier,” Dr. Pilla said. Earlier bedtimes may put an end sooner to the daily eating pattern.

Subanalyses of the data are ongoing and will be published later.

“In the context of several clinical trials that suggest a benefit of TRE, our findings suggest that if or when TRE interventions induce weight loss, it is likely in part due to a reduction in energy intake, and therefore, clinicians can counsel patients that TRE may help them lose weight by decreasing their caloric intake,” the authors wrote.

In an accompanying editorial, Krista A. Varady, PhD, and Vanessa M. Oddo, PhD, of the Department of Kinesiology and Nutrition at the University of Illinois–Chicago, said the study results have important clinical implications. “Many patients stop following standard-care diets (such as daily calorie restriction) because they become frustrated with having to monitor food intake vigilantly each day,” they wrote.

Gastroenterologists and Obesity

Of late, support has grown for gastroenterologists to become actively involved in obesity treatment — even to “take ownership” of this field.

In a 2023 article in Gut, Michael Camilleri, MD, AGAF, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota, made the case for the natural fit between gastrointestinal (GI) specialists and obesity management. He noted that obesity is a significant risk factor for GI, pancreatic, and liver diseases. It can even affect inflammatory bowel disease.

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

In the setting of isocaloric eating, time-restricted eating (TRE) did not reduce weight or improve glucose homeostasis relative to a usual eating pattern (UEP), a small randomized controlled trial found.

The results suggested that any effects of TRE on weight observed in prior studies may be due to reductions in caloric intake and not timing, according to Nisa M. Maruthur, MD, MHS, of the Division of General Internal Medicine at the Johns Hopkins School of Medicine in Baltimore, and colleagues.

Published in Annals of Internal Medicine, the 12-week trial randomly assigned 41 adults aged 18-69 years with obesity and prediabetes or diet-controlled diabetes 1:1 as follows: To TRE, involving a 10-hour eating window with 80% of calories consumed before 1 PM, or to UEP, involving a ≤ 16-hour window, with at least 50% of calories consumed after 5 PM. The regimen in each group was based on the OmniHeart unsaturated fat diet and the SPICE study.

“The diet was similar to the DASH [Dietary Approaches to Stop Hypertension] diet for hypertension and maybe a bit higher in unsaturated fat and micronutrients,” said study co-author Scott J. Pilla, MD, MHS, an assistant professor of medicine at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. For each participant, macro- and micronutrient content remained constant throughout the study period, with total calories individually determined at baseline and ranging from 1600 to 3500 kcal/d. “That differs from some TRE studies in which calories were adjusted according to whether participants lost or gained weight,” he said. “This was a purely mechanistic study to determine the impact of time of eating alone with no change in calories.”

The Cohort

The mean age was 59 years, 93% of patients were women, and 93% were Black. The mean body mass index was 36, and the mean baseline weight was 96.2 kg — 95.6 kg in the TRE group and 103.7 kg in the UEP group.

At 12 weeks, weight decreased comparably by 2.3 kg (95% CI, 1.0-3.5) in the TRE group and by 2.6 kg (95% CI, 1.5-3.7) in the UEP group. Change in glycemic measures did not differ between the two groups.

Interestingly, self-reporting questionnaires revealed a slight reduction in physical activity in the TRE group, an effect that requires further study. “We don’t know why but anecdotally, some TRE participants said they tended to go to bed earlier,” Dr. Pilla said. Earlier bedtimes may put an end sooner to the daily eating pattern.

Subanalyses of the data are ongoing and will be published later.

“In the context of several clinical trials that suggest a benefit of TRE, our findings suggest that if or when TRE interventions induce weight loss, it is likely in part due to a reduction in energy intake, and therefore, clinicians can counsel patients that TRE may help them lose weight by decreasing their caloric intake,” the authors wrote.

In an accompanying editorial, Krista A. Varady, PhD, and Vanessa M. Oddo, PhD, of the Department of Kinesiology and Nutrition at the University of Illinois–Chicago, said the study results have important clinical implications. “Many patients stop following standard-care diets (such as daily calorie restriction) because they become frustrated with having to monitor food intake vigilantly each day,” they wrote.

Gastroenterologists and Obesity

Of late, support has grown for gastroenterologists to become actively involved in obesity treatment — even to “take ownership” of this field.

In a 2023 article in Gut, Michael Camilleri, MD, AGAF, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota, made the case for the natural fit between gastrointestinal (GI) specialists and obesity management. He noted that obesity is a significant risk factor for GI, pancreatic, and liver diseases. It can even affect inflammatory bowel disease.

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

In the setting of isocaloric eating, time-restricted eating (TRE) did not reduce weight or improve glucose homeostasis relative to a usual eating pattern (UEP), a small randomized controlled trial found.

The results suggested that any effects of TRE on weight observed in prior studies may be due to reductions in caloric intake and not timing, according to Nisa M. Maruthur, MD, MHS, of the Division of General Internal Medicine at the Johns Hopkins School of Medicine in Baltimore, and colleagues.

Published in Annals of Internal Medicine, the 12-week trial randomly assigned 41 adults aged 18-69 years with obesity and prediabetes or diet-controlled diabetes 1:1 as follows: To TRE, involving a 10-hour eating window with 80% of calories consumed before 1 PM, or to UEP, involving a ≤ 16-hour window, with at least 50% of calories consumed after 5 PM. The regimen in each group was based on the OmniHeart unsaturated fat diet and the SPICE study.

“The diet was similar to the DASH [Dietary Approaches to Stop Hypertension] diet for hypertension and maybe a bit higher in unsaturated fat and micronutrients,” said study co-author Scott J. Pilla, MD, MHS, an assistant professor of medicine at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. For each participant, macro- and micronutrient content remained constant throughout the study period, with total calories individually determined at baseline and ranging from 1600 to 3500 kcal/d. “That differs from some TRE studies in which calories were adjusted according to whether participants lost or gained weight,” he said. “This was a purely mechanistic study to determine the impact of time of eating alone with no change in calories.”

The Cohort

The mean age was 59 years, 93% of patients were women, and 93% were Black. The mean body mass index was 36, and the mean baseline weight was 96.2 kg — 95.6 kg in the TRE group and 103.7 kg in the UEP group.

At 12 weeks, weight decreased comparably by 2.3 kg (95% CI, 1.0-3.5) in the TRE group and by 2.6 kg (95% CI, 1.5-3.7) in the UEP group. Change in glycemic measures did not differ between the two groups.

Interestingly, self-reporting questionnaires revealed a slight reduction in physical activity in the TRE group, an effect that requires further study. “We don’t know why but anecdotally, some TRE participants said they tended to go to bed earlier,” Dr. Pilla said. Earlier bedtimes may put an end sooner to the daily eating pattern.

Subanalyses of the data are ongoing and will be published later.

“In the context of several clinical trials that suggest a benefit of TRE, our findings suggest that if or when TRE interventions induce weight loss, it is likely in part due to a reduction in energy intake, and therefore, clinicians can counsel patients that TRE may help them lose weight by decreasing their caloric intake,” the authors wrote.

In an accompanying editorial, Krista A. Varady, PhD, and Vanessa M. Oddo, PhD, of the Department of Kinesiology and Nutrition at the University of Illinois–Chicago, said the study results have important clinical implications. “Many patients stop following standard-care diets (such as daily calorie restriction) because they become frustrated with having to monitor food intake vigilantly each day,” they wrote.

Gastroenterologists and Obesity

Of late, support has grown for gastroenterologists to become actively involved in obesity treatment — even to “take ownership” of this field.

In a 2023 article in Gut, Michael Camilleri, MD, AGAF, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota, made the case for the natural fit between gastrointestinal (GI) specialists and obesity management. He noted that obesity is a significant risk factor for GI, pancreatic, and liver diseases. It can even affect inflammatory bowel disease.

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

Our son works for a Maine-based company that produces and sells clothing and outdoor recreation equipment. One of its tag lines is “Be an Outsider.” In his role as chief marketing officer, he was recently given an app for his phone that can calculate how many minutes he spends outside each day. He assured me: “Dad, you don’t need one of these on your phone. Your weather-beaten skin says you are already logging in way more than enough minutes outdoors.”

But, it got me thinking about several avenues of research where an app like that would be useful. As luck would have it, the following week I stumbled across a paper describing just such a study.

Researchers in Shanghai, China, placed smartwatches with technology similar to my son’s phone on nearly 3000 children and found “that outdoor exposure patterns characterized by a continuous period of at least 15 minutes, accompanied by a sunlight intensity of more than 2000 lux, were associated with less myopic shift.” In other words, children getting more time outside were less likely to become nearsighted.” Whether this was an effect of being outside instead of staring at a screen indoors is an interesting question.

I have alway suspected that being outdoors was important for wellness and this paper meshed nicely with an article I had recently read in The Washington Post titled, “How time in nature builds happier, healthier and more social children” (Jamie Friedlander Serrano, 2024 Aug 4). The reporter quotes numerous experts in child health and includes links to several articles that tout the benefits of outdoor experiences, particularly ones in a natural environment. There are the vitamin D effects on growth and bone health. There are studies suggesting that being out in nature can reduce stress, anxiety, and aggression, and improve working memory and attention.

In this country there is a small but growing group of schools modeling themselves after the “Forest kindergartens” that have become popular in Europe in which a large portion of the students’ days are spent outside surrounded by nature. It will be interesting to see how robustly this trend grows here in the United States. However, in a nation like ours in which the Environmental Protection Agency estimates that the average American spends 90% of his day indoors, it’s going to require a seismic shift in our societal norms.

I think my mother always knew that being outdoors was healthy for children. I also suspect that she and most my friends’ mothers were primarily motivated by a desire to have the house to themselves. This was primarily to allow them to get the housework done unimpeded by pestering children. But, there may have been times when a busy housewife simply needed to sit down with a book in the peace and quiet of a childless environment. We kids were told to get out of the house and return for lunch and dinner, hopefully not in the tow of a police officer. There were few rules and for the most part we were left to invent our own amusement.

Yes, you’ve heard this old-fogey legend before. But it was true. Those were the halcyon days of the 1950s in a small suburban town of 5000 of a little more than 1 square mile with its own swimming pool. My particular idyll was aptly named Pleasantville but I know we were not alone as the only community where children were allowed – or let’s say “encouraged” – to be outdoors if they weren’t in school. It was a different time.

I am not so naive to believe that we will ever return to those good old days when children roamed free, but it is worth considering what has changed to drive children inside and away from all the health benefits of being outdoors. Is there anything we can do to reverse this unfortunate trend?

First, we must first face up to the reality that our society has become so focused on the potential downsides of everything that we seem to be driven primarily by risk avoidance. We hear how things can go terribly wrong in the world outside, a world we can’t control. Although the data from the pandemic don’t support it, more of us believe children are safer indoors. Parents in particular seem to worry more now than they did 75 years ago. I don’t think we can point to a single event such as the tragedies of September 11 to explain the shift.

While bad news has always traveled fast, today (with communication being almost instantaneous) a story about a child abduction at 6 in the morning in Nevada can be on my local TV channel by lunchtime here in Maine. Parents worry that if bad stuff can happen to a child in Mount Elsewhere, it could happen to my child playing in the backyard across the street.

I think we pediatricians should consider how large a role we may be playing in driving parental anxiety with our frequent warnings about the dangers a child can encounter outdoors whether they come in the form of accidents or exposure to the elements.

While parents have grown more hesitant to send their children outside to play, as a society we have failed to adequately acknowledge and respond to the role that unhealthy attraction of indoor alternatives to outdoor play may be contributing to indoorism. Here we’re talking about television, smartphones, and the internet.

So, what can we do as pediatricians to get our patients outside? First, we can set an example and cover our office walls with pictures of ourselves and our families enjoying the outdoors. We can be vocal advocates for creating and maintaining accessible outdoor spaces in our community. We can advocate for more outside time during recess in school and encourage the school officials to consider having more courses taught outside.

We can be more diligent in asking families about their screen use and not be afraid to express our concern when we hear how little outdoor time their child is getting. Finally, we can strive for more balance in our messaging. For example for every warning we give about playing outside on poor air quality days there should be a reminder of the health benefits of being outdoors on the other days. Every message about the importance of sunscreen should be preceded by a few sentences promoting outdoor activities in wooded environments where sun exposure is less of a concern.

We should all be looking for ways in which our communities can remove the barriers that prevent our patients for reaping the health benefits of being outdoors. Being an outsider is just as important as getting enough sleep, eating the right food and staying physically active.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Our son works for a Maine-based company that produces and sells clothing and outdoor recreation equipment. One of its tag lines is “Be an Outsider.” In his role as chief marketing officer, he was recently given an app for his phone that can calculate how many minutes he spends outside each day. He assured me: “Dad, you don’t need one of these on your phone. Your weather-beaten skin says you are already logging in way more than enough minutes outdoors.”

But, it got me thinking about several avenues of research where an app like that would be useful. As luck would have it, the following week I stumbled across a paper describing just such a study.

Researchers in Shanghai, China, placed smartwatches with technology similar to my son’s phone on nearly 3000 children and found “that outdoor exposure patterns characterized by a continuous period of at least 15 minutes, accompanied by a sunlight intensity of more than 2000 lux, were associated with less myopic shift.” In other words, children getting more time outside were less likely to become nearsighted.” Whether this was an effect of being outside instead of staring at a screen indoors is an interesting question.

I have alway suspected that being outdoors was important for wellness and this paper meshed nicely with an article I had recently read in The Washington Post titled, “How time in nature builds happier, healthier and more social children” (Jamie Friedlander Serrano, 2024 Aug 4). The reporter quotes numerous experts in child health and includes links to several articles that tout the benefits of outdoor experiences, particularly ones in a natural environment. There are the vitamin D effects on growth and bone health. There are studies suggesting that being out in nature can reduce stress, anxiety, and aggression, and improve working memory and attention.

In this country there is a small but growing group of schools modeling themselves after the “Forest kindergartens” that have become popular in Europe in which a large portion of the students’ days are spent outside surrounded by nature. It will be interesting to see how robustly this trend grows here in the United States. However, in a nation like ours in which the Environmental Protection Agency estimates that the average American spends 90% of his day indoors, it’s going to require a seismic shift in our societal norms.

I think my mother always knew that being outdoors was healthy for children. I also suspect that she and most my friends’ mothers were primarily motivated by a desire to have the house to themselves. This was primarily to allow them to get the housework done unimpeded by pestering children. But, there may have been times when a busy housewife simply needed to sit down with a book in the peace and quiet of a childless environment. We kids were told to get out of the house and return for lunch and dinner, hopefully not in the tow of a police officer. There were few rules and for the most part we were left to invent our own amusement.

Yes, you’ve heard this old-fogey legend before. But it was true. Those were the halcyon days of the 1950s in a small suburban town of 5000 of a little more than 1 square mile with its own swimming pool. My particular idyll was aptly named Pleasantville but I know we were not alone as the only community where children were allowed – or let’s say “encouraged” – to be outdoors if they weren’t in school. It was a different time.

I am not so naive to believe that we will ever return to those good old days when children roamed free, but it is worth considering what has changed to drive children inside and away from all the health benefits of being outdoors. Is there anything we can do to reverse this unfortunate trend?

First, we must first face up to the reality that our society has become so focused on the potential downsides of everything that we seem to be driven primarily by risk avoidance. We hear how things can go terribly wrong in the world outside, a world we can’t control. Although the data from the pandemic don’t support it, more of us believe children are safer indoors. Parents in particular seem to worry more now than they did 75 years ago. I don’t think we can point to a single event such as the tragedies of September 11 to explain the shift.

While bad news has always traveled fast, today (with communication being almost instantaneous) a story about a child abduction at 6 in the morning in Nevada can be on my local TV channel by lunchtime here in Maine. Parents worry that if bad stuff can happen to a child in Mount Elsewhere, it could happen to my child playing in the backyard across the street.

I think we pediatricians should consider how large a role we may be playing in driving parental anxiety with our frequent warnings about the dangers a child can encounter outdoors whether they come in the form of accidents or exposure to the elements.

While parents have grown more hesitant to send their children outside to play, as a society we have failed to adequately acknowledge and respond to the role that unhealthy attraction of indoor alternatives to outdoor play may be contributing to indoorism. Here we’re talking about television, smartphones, and the internet.

So, what can we do as pediatricians to get our patients outside? First, we can set an example and cover our office walls with pictures of ourselves and our families enjoying the outdoors. We can be vocal advocates for creating and maintaining accessible outdoor spaces in our community. We can advocate for more outside time during recess in school and encourage the school officials to consider having more courses taught outside.

We can be more diligent in asking families about their screen use and not be afraid to express our concern when we hear how little outdoor time their child is getting. Finally, we can strive for more balance in our messaging. For example for every warning we give about playing outside on poor air quality days there should be a reminder of the health benefits of being outdoors on the other days. Every message about the importance of sunscreen should be preceded by a few sentences promoting outdoor activities in wooded environments where sun exposure is less of a concern.

We should all be looking for ways in which our communities can remove the barriers that prevent our patients for reaping the health benefits of being outdoors. Being an outsider is just as important as getting enough sleep, eating the right food and staying physically active.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Our son works for a Maine-based company that produces and sells clothing and outdoor recreation equipment. One of its tag lines is “Be an Outsider.” In his role as chief marketing officer, he was recently given an app for his phone that can calculate how many minutes he spends outside each day. He assured me: “Dad, you don’t need one of these on your phone. Your weather-beaten skin says you are already logging in way more than enough minutes outdoors.”

But, it got me thinking about several avenues of research where an app like that would be useful. As luck would have it, the following week I stumbled across a paper describing just such a study.

Researchers in Shanghai, China, placed smartwatches with technology similar to my son’s phone on nearly 3000 children and found “that outdoor exposure patterns characterized by a continuous period of at least 15 minutes, accompanied by a sunlight intensity of more than 2000 lux, were associated with less myopic shift.” In other words, children getting more time outside were less likely to become nearsighted.” Whether this was an effect of being outside instead of staring at a screen indoors is an interesting question.

I have alway suspected that being outdoors was important for wellness and this paper meshed nicely with an article I had recently read in The Washington Post titled, “How time in nature builds happier, healthier and more social children” (Jamie Friedlander Serrano, 2024 Aug 4). The reporter quotes numerous experts in child health and includes links to several articles that tout the benefits of outdoor experiences, particularly ones in a natural environment. There are the vitamin D effects on growth and bone health. There are studies suggesting that being out in nature can reduce stress, anxiety, and aggression, and improve working memory and attention.

In this country there is a small but growing group of schools modeling themselves after the “Forest kindergartens” that have become popular in Europe in which a large portion of the students’ days are spent outside surrounded by nature. It will be interesting to see how robustly this trend grows here in the United States. However, in a nation like ours in which the Environmental Protection Agency estimates that the average American spends 90% of his day indoors, it’s going to require a seismic shift in our societal norms.

I think my mother always knew that being outdoors was healthy for children. I also suspect that she and most my friends’ mothers were primarily motivated by a desire to have the house to themselves. This was primarily to allow them to get the housework done unimpeded by pestering children. But, there may have been times when a busy housewife simply needed to sit down with a book in the peace and quiet of a childless environment. We kids were told to get out of the house and return for lunch and dinner, hopefully not in the tow of a police officer. There were few rules and for the most part we were left to invent our own amusement.

Yes, you’ve heard this old-fogey legend before. But it was true. Those were the halcyon days of the 1950s in a small suburban town of 5000 of a little more than 1 square mile with its own swimming pool. My particular idyll was aptly named Pleasantville but I know we were not alone as the only community where children were allowed – or let’s say “encouraged” – to be outdoors if they weren’t in school. It was a different time.

I am not so naive to believe that we will ever return to those good old days when children roamed free, but it is worth considering what has changed to drive children inside and away from all the health benefits of being outdoors. Is there anything we can do to reverse this unfortunate trend?

First, we must first face up to the reality that our society has become so focused on the potential downsides of everything that we seem to be driven primarily by risk avoidance. We hear how things can go terribly wrong in the world outside, a world we can’t control. Although the data from the pandemic don’t support it, more of us believe children are safer indoors. Parents in particular seem to worry more now than they did 75 years ago. I don’t think we can point to a single event such as the tragedies of September 11 to explain the shift.

While bad news has always traveled fast, today (with communication being almost instantaneous) a story about a child abduction at 6 in the morning in Nevada can be on my local TV channel by lunchtime here in Maine. Parents worry that if bad stuff can happen to a child in Mount Elsewhere, it could happen to my child playing in the backyard across the street.

I think we pediatricians should consider how large a role we may be playing in driving parental anxiety with our frequent warnings about the dangers a child can encounter outdoors whether they come in the form of accidents or exposure to the elements.

While parents have grown more hesitant to send their children outside to play, as a society we have failed to adequately acknowledge and respond to the role that unhealthy attraction of indoor alternatives to outdoor play may be contributing to indoorism. Here we’re talking about television, smartphones, and the internet.

So, what can we do as pediatricians to get our patients outside? First, we can set an example and cover our office walls with pictures of ourselves and our families enjoying the outdoors. We can be vocal advocates for creating and maintaining accessible outdoor spaces in our community. We can advocate for more outside time during recess in school and encourage the school officials to consider having more courses taught outside.

We can be more diligent in asking families about their screen use and not be afraid to express our concern when we hear how little outdoor time their child is getting. Finally, we can strive for more balance in our messaging. For example for every warning we give about playing outside on poor air quality days there should be a reminder of the health benefits of being outdoors on the other days. Every message about the importance of sunscreen should be preceded by a few sentences promoting outdoor activities in wooded environments where sun exposure is less of a concern.

We should all be looking for ways in which our communities can remove the barriers that prevent our patients for reaping the health benefits of being outdoors. Being an outsider is just as important as getting enough sleep, eating the right food and staying physically active.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

TOPLINE:

The metabolically unhealthy obesity phenotype, with its multiple comorbidities, may be the most practical group of people with obesity to screen for Cushing syndrome rather than all patients with obesity.

METHODOLOGY:

• Obesity is a key clinical feature of Cushing syndrome and shares many overlapping characteristics. An ongoing debate continues about the need to screen patients with obesity for the rare endocrine disease, but phenotypes known as metabolically healthy or unhealthy obesity may help better define an at-risk population.
• To assess the prevalence of Cushing syndrome by metabolic health status, researchers conducted a retrospective study of 1008 patients with obesity (mean age, 40 years; 83% women; body mass index ≥ 30) seen at an endocrinology outpatient clinic in Turkey between December 2020 and June 2022.
• They screened patients for Cushing syndrome with an overnight dexamethasone suppression test (1 mg DST), an oral dexamethasone dose given at 11 PM followed by a fasting blood sample for cortisol measurement the next morning. A serum cortisol level < 1.8 mcg/dL indicated normal suppression.
• Patients were categorized into those with metabolically healthy obesity (n = 229) or metabolically unhealthy obesity (n = 779) based on the absence or presence of comorbidities such as diabetes, prediabetes, coronary artery disease, hypertension, or dyslipidemia.

TAKEAWAY:

• The overall prevalence of Cushing syndrome in the study cohort was 0.2%, with only two patients definitively diagnosed after more tests and the remaining 10 classified as having subclinical hypercortisolism.
• Cortisol levels following the 1 mg DST were higher in the metabolically unhealthy obesity group than in the metabolically healthy obesity group (P = .001).
• Among the 12 patients with unsuppressed levels of cortisol, 11 belonged to the metabolically unhealthy obesity group, indicating a strong association between metabolic health and the levels of cortisol.
• The test demonstrated a specificity of 99% and sensitivity of 100% for screening Cushing syndrome in patients with obesity.

IN PRACTICE:

“Screening all patients with obesity for CS [Cushing syndrome] without considering any associated metabolic conditions appears impractical and unnecessary in everyday clinical practice,” the authors wrote. “However, it may be more reasonable and applicable to selectively screen the patients with obesity having comorbidities such as DM [diabetes mellitus], hypertension, dyslipidemia, or coronary artery disease, which lead to a metabolically unhealthy phenotype, rather than all individuals with obesity,” they added.

SOURCE:

The study, led by Sema Hepsen, Ankara Etlik City Hospital, Department of Endocrinology and Metabolism, Ankara, Turkey, was published online in the International Journal of Obesity.

LIMITATIONS:

The single-center design of the study and inclusion of patients from a single racial group may limit the generalizability of the findings. The retrospective design prevented the retrieval of all relevant data on clinical features and fat distribution.

DISCLOSURES:

The study was supported by an open access funding provided by the Scientific and Technological Research Council of Türkiye. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The metabolically unhealthy obesity phenotype, with its multiple comorbidities, may be the most practical group of people with obesity to screen for Cushing syndrome rather than all patients with obesity.

METHODOLOGY:

• Obesity is a key clinical feature of Cushing syndrome and shares many overlapping characteristics. An ongoing debate continues about the need to screen patients with obesity for the rare endocrine disease, but phenotypes known as metabolically healthy or unhealthy obesity may help better define an at-risk population.
• To assess the prevalence of Cushing syndrome by metabolic health status, researchers conducted a retrospective study of 1008 patients with obesity (mean age, 40 years; 83% women; body mass index ≥ 30) seen at an endocrinology outpatient clinic in Turkey between December 2020 and June 2022.
• They screened patients for Cushing syndrome with an overnight dexamethasone suppression test (1 mg DST), an oral dexamethasone dose given at 11 PM followed by a fasting blood sample for cortisol measurement the next morning. A serum cortisol level < 1.8 mcg/dL indicated normal suppression.
• Patients were categorized into those with metabolically healthy obesity (n = 229) or metabolically unhealthy obesity (n = 779) based on the absence or presence of comorbidities such as diabetes, prediabetes, coronary artery disease, hypertension, or dyslipidemia.

TAKEAWAY:

• The overall prevalence of Cushing syndrome in the study cohort was 0.2%, with only two patients definitively diagnosed after more tests and the remaining 10 classified as having subclinical hypercortisolism.
• Cortisol levels following the 1 mg DST were higher in the metabolically unhealthy obesity group than in the metabolically healthy obesity group (P = .001).
• Among the 12 patients with unsuppressed levels of cortisol, 11 belonged to the metabolically unhealthy obesity group, indicating a strong association between metabolic health and the levels of cortisol.
• The test demonstrated a specificity of 99% and sensitivity of 100% for screening Cushing syndrome in patients with obesity.

IN PRACTICE:

“Screening all patients with obesity for CS [Cushing syndrome] without considering any associated metabolic conditions appears impractical and unnecessary in everyday clinical practice,” the authors wrote. “However, it may be more reasonable and applicable to selectively screen the patients with obesity having comorbidities such as DM [diabetes mellitus], hypertension, dyslipidemia, or coronary artery disease, which lead to a metabolically unhealthy phenotype, rather than all individuals with obesity,” they added.

SOURCE:

The study, led by Sema Hepsen, Ankara Etlik City Hospital, Department of Endocrinology and Metabolism, Ankara, Turkey, was published online in the International Journal of Obesity.

LIMITATIONS:

The single-center design of the study and inclusion of patients from a single racial group may limit the generalizability of the findings. The retrospective design prevented the retrieval of all relevant data on clinical features and fat distribution.

DISCLOSURES:

The study was supported by an open access funding provided by the Scientific and Technological Research Council of Türkiye. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The metabolically unhealthy obesity phenotype, with its multiple comorbidities, may be the most practical group of people with obesity to screen for Cushing syndrome rather than all patients with obesity.

METHODOLOGY:

• Obesity is a key clinical feature of Cushing syndrome and shares many overlapping characteristics. An ongoing debate continues about the need to screen patients with obesity for the rare endocrine disease, but phenotypes known as metabolically healthy or unhealthy obesity may help better define an at-risk population.
• To assess the prevalence of Cushing syndrome by metabolic health status, researchers conducted a retrospective study of 1008 patients with obesity (mean age, 40 years; 83% women; body mass index ≥ 30) seen at an endocrinology outpatient clinic in Turkey between December 2020 and June 2022.
• They screened patients for Cushing syndrome with an overnight dexamethasone suppression test (1 mg DST), an oral dexamethasone dose given at 11 PM followed by a fasting blood sample for cortisol measurement the next morning. A serum cortisol level < 1.8 mcg/dL indicated normal suppression.
• Patients were categorized into those with metabolically healthy obesity (n = 229) or metabolically unhealthy obesity (n = 779) based on the absence or presence of comorbidities such as diabetes, prediabetes, coronary artery disease, hypertension, or dyslipidemia.

TAKEAWAY:

• The overall prevalence of Cushing syndrome in the study cohort was 0.2%, with only two patients definitively diagnosed after more tests and the remaining 10 classified as having subclinical hypercortisolism.
• Cortisol levels following the 1 mg DST were higher in the metabolically unhealthy obesity group than in the metabolically healthy obesity group (P = .001).
• Among the 12 patients with unsuppressed levels of cortisol, 11 belonged to the metabolically unhealthy obesity group, indicating a strong association between metabolic health and the levels of cortisol.
• The test demonstrated a specificity of 99% and sensitivity of 100% for screening Cushing syndrome in patients with obesity.

IN PRACTICE:

“Screening all patients with obesity for CS [Cushing syndrome] without considering any associated metabolic conditions appears impractical and unnecessary in everyday clinical practice,” the authors wrote. “However, it may be more reasonable and applicable to selectively screen the patients with obesity having comorbidities such as DM [diabetes mellitus], hypertension, dyslipidemia, or coronary artery disease, which lead to a metabolically unhealthy phenotype, rather than all individuals with obesity,” they added.

SOURCE:

The study, led by Sema Hepsen, Ankara Etlik City Hospital, Department of Endocrinology and Metabolism, Ankara, Turkey, was published online in the International Journal of Obesity.

LIMITATIONS:

The single-center design of the study and inclusion of patients from a single racial group may limit the generalizability of the findings. The retrospective design prevented the retrieval of all relevant data on clinical features and fat distribution.

DISCLOSURES:

The study was supported by an open access funding provided by the Scientific and Technological Research Council of Türkiye. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

A so-called “oatzempic” diet has been bouncing around the internet posing as a cheap — and available — weight loss alternative to Ozempic.

Fans of the diet, made trendy by TikTok postings and a clever name, claim that an oat-based smoothie helps people quickly shed lots of weight. The smoothie is made by blending 1/2 cup of oats, 1 cup of water, a squeeze of lime, and maybe a dash of cinnamon or other flavoring agents, typically as the first meal of the day, often after fasting, followed by normal meals.

Despite the hype, the oatzempic drink is a far cry from Ozempic (semaglutide), the glucagon-like peptide 1 (GLP-1) medication the Food and Drug Administration has approved only for type 2 diabetes management but used off label for weight loss.

So how do pulverized oats stack up against prescription-based GLP-1s? According to two nutrition experts, they’re not as effective as some TikTok influencers claim. And in people with diabetes, the diet can be dangerous.
 

Nutritionists Answer Questions on Oatzempic

Caroline West Passerrello, EdD, RDN, LDN, an instructor and community coordinator in the School of Health and Rehabilitation Sciences at the University of Pittsburgh, Pennsylvania, and Emma Laing, PhD, RDN, LD, a clinical professor and director of dietetics in the College of Family and Consumer Sciences at the University of Georgia, Athens, talked about this fad in emails.

Can the ‘oatzempic’ diet help people lose weight?

Dr. Passerrello: Oats are particularly high in soluble fiber, and high-fiber foods can increase the natural production of GLPs. But studies are mixed on whether this happens when eating oats.

The high content of soluble beta-glucan fiber in oats and the appetite-suppressing citric acid in lime can potentially promote decreased appetite and increased satiety. But a bowl of oatmeal, though not as trendy, will probably produce the same results.

Is the oatzempic diet safe for people with type 2 diabetes?

Dr. Laing: This diet has the potential to cause harm. The diet and the drug are not similar in mechanism of action or strength of scientific evidence to support their role in diabetes and weight management. There is no evidence that this concoction provides the same outcomes as GLP-1 agonists. Rapid weight loss is unsustainable and can be harmful, and frequent spikes in blood sugar can harm adults and children with diabetes. So the oatzempic diet’s safety depends on the rate of weight loss and the effect on blood sugar. While it provides beta-glucan from oats and citric acid from lime juice, it is missing protein, healthy fats, and other vitamins and minerals that enhance the nutrient content and stabilize blood sugar.

Maintaining relatively consistent, normal-range blood glucose concentrations is key for managing diabetes and lowering the risks for other health complications. Carbohydrate sources consumed on their own can produce greater blood sugar fluctuations than when combined with proteins and fats, which slow carbohydrate digestion speed. So pairing oats with fruits, vegetables, healthy fats, and protein sources enhances the flavor, texture, and nutrient composition of the dish and can help slow the postprandial rise in blood glucose.

In the long term, any restrictive fad diet likely cannot be sustained and increases the risk for malnutrition, metabolic rate slowing to conserve energy, depression, social isolation, or eating disorder.

Additional considerations apply to children, with or without diabetes. Restrictive, extreme diets that promise quick results typically “work” by promoting body water and muscle mass losses. Such diets are not only contraindicated in children, who are undergoing rapid growth and development, but also unsustainable and can lead to physical and psychological problems that carry into adulthood.

What strategies and tactics can physicians use to effectively communicate with their patients about safe and effective diets?

Dr. Laing: Encourage patients to be skeptical of social media trends that seem too good to be true. Many [social media] creators lack the education or professional credentials to offer sound nutrition advice, and their posts could do harm. Explain that individual nutrition needs differ considerably based on age, activity patterns, health conditions, and medications, and one person’s way of eating or success is often not realistic for someone else.

Encourage open dialogue and provide nonjudgmental advice. If the taste of oatzempic intrigues patients, there is likely no harm in experimenting. Work on ensuring their meals are adequate in calories and contain sources of protein and healthy fats to prevent spikes in blood glucose. It’s crucial to communicate that weight loss doesn’t always equate with improved health.

Sharing information from the Academy of Nutrition and Dietetics and the American Diabetes Association can equip patients with tools they can implement under their clinician’s guidance. A provider’s greatest ally in diabetes care is a registered dietitian nutritionist (RDN) who is a Certified Diabetes Care and Education Specialist. RDNs will determine specific energy and nutrient needs and provide medical nutrition therapy such as carbohydrate counting, simplified meal plans, healthy food choices, exchange lists, and behavior strategies to help patients manage their diabetes. Many insurance plans cover these services.

What additional comments would you like to share with clinicians whose patients may ask them about the oatzempic diet?

Dr. Passerrello: What we do consistently matters. If your patient likes the taste of oatzempic in one meal a day, it’s a way to get more oats into their diet, if they focus their other meals on vegetables, fruits, whole grains, lean protein, and unsaturated fats.

Diets are out, and sustainable dietary patterns are in. Diets are one-size-fits-all, whereas a sustainable dietary pattern is individualized based on a person’s goals, medical history, taste preferences, budget, and lifestyle. Visit MyPlate.gov or work with an RDN [visit https://www.eatright.org/find-a-nutrition-expert to find nutritionists near your patients] to determine what a sustainable dietary pattern looks like.

What do clinicians need to know about claims on social media that a related drink — ‘ricezempic’ — aids weight loss?

Dr. Laing: Ricezempic promoters claim that drinking the beverage — typically made by soaking 1/2 cup of uncooked white rice in 1 cup of water and the juice from half a lime, then discarding the rice and drinking the liquid before breakfast — will lead to weight loss because the strained water provides a small dose of resistant starch, which is a source of prebiotics. Studies have shown that ingesting prebiotics may help lower blood cholesterol, improve blood glucose and insulin sensitivity, and benefit digestive function; however, more research is needed to determine specifics and if prebiotics are proven for weight loss.

Does ricezempic work?

Dr. Laing: There is no evidence that this concoction provides the same outcomes as GLP-1 agonists. The diet and the drug are not similar in mechanism of action or strength of scientific evidence to support their role in diabetes and weight management. Even if ricezempic provides a small amount of resistant starch and hydration from the rice water and citric acid from the lime juice, it is missing fiber, protein, healthy fats, and other vitamins and minerals that enhance the nutrient content of a meal or snack and stabilize blood sugar.

What advice do you have for clinicians whose patients with diabetes ask them about ricezempic?

Dr. Laing: I would not suggest that patients rely on ricezempic to support their health. There is no scientific evidence to show that people will lose weight in the short or long term by drinking ricezempic before a meal (or as a meal replacement).

If your patients are aiming to increase their intake of prebiotics, they are naturally found in various vegetables, fruits, whole grains, and seeds and in yogurt and high-fiber breads and cereals. A nutritious eating pattern that includes these foods is most beneficial for health.

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

A so-called “oatzempic” diet has been bouncing around the internet posing as a cheap — and available — weight loss alternative to Ozempic.

Fans of the diet, made trendy by TikTok postings and a clever name, claim that an oat-based smoothie helps people quickly shed lots of weight. The smoothie is made by blending 1/2 cup of oats, 1 cup of water, a squeeze of lime, and maybe a dash of cinnamon or other flavoring agents, typically as the first meal of the day, often after fasting, followed by normal meals.

Despite the hype, the oatzempic drink is a far cry from Ozempic (semaglutide), the glucagon-like peptide 1 (GLP-1) medication the Food and Drug Administration has approved only for type 2 diabetes management but used off label for weight loss.

So how do pulverized oats stack up against prescription-based GLP-1s? According to two nutrition experts, they’re not as effective as some TikTok influencers claim. And in people with diabetes, the diet can be dangerous.
 

Nutritionists Answer Questions on Oatzempic

Caroline West Passerrello, EdD, RDN, LDN, an instructor and community coordinator in the School of Health and Rehabilitation Sciences at the University of Pittsburgh, Pennsylvania, and Emma Laing, PhD, RDN, LD, a clinical professor and director of dietetics in the College of Family and Consumer Sciences at the University of Georgia, Athens, talked about this fad in emails.

Can the ‘oatzempic’ diet help people lose weight?

Dr. Passerrello: Oats are particularly high in soluble fiber, and high-fiber foods can increase the natural production of GLPs. But studies are mixed on whether this happens when eating oats.

The high content of soluble beta-glucan fiber in oats and the appetite-suppressing citric acid in lime can potentially promote decreased appetite and increased satiety. But a bowl of oatmeal, though not as trendy, will probably produce the same results.

Is the oatzempic diet safe for people with type 2 diabetes?

Dr. Laing: This diet has the potential to cause harm. The diet and the drug are not similar in mechanism of action or strength of scientific evidence to support their role in diabetes and weight management. There is no evidence that this concoction provides the same outcomes as GLP-1 agonists. Rapid weight loss is unsustainable and can be harmful, and frequent spikes in blood sugar can harm adults and children with diabetes. So the oatzempic diet’s safety depends on the rate of weight loss and the effect on blood sugar. While it provides beta-glucan from oats and citric acid from lime juice, it is missing protein, healthy fats, and other vitamins and minerals that enhance the nutrient content and stabilize blood sugar.

Maintaining relatively consistent, normal-range blood glucose concentrations is key for managing diabetes and lowering the risks for other health complications. Carbohydrate sources consumed on their own can produce greater blood sugar fluctuations than when combined with proteins and fats, which slow carbohydrate digestion speed. So pairing oats with fruits, vegetables, healthy fats, and protein sources enhances the flavor, texture, and nutrient composition of the dish and can help slow the postprandial rise in blood glucose.

In the long term, any restrictive fad diet likely cannot be sustained and increases the risk for malnutrition, metabolic rate slowing to conserve energy, depression, social isolation, or eating disorder.

Additional considerations apply to children, with or without diabetes. Restrictive, extreme diets that promise quick results typically “work” by promoting body water and muscle mass losses. Such diets are not only contraindicated in children, who are undergoing rapid growth and development, but also unsustainable and can lead to physical and psychological problems that carry into adulthood.

What strategies and tactics can physicians use to effectively communicate with their patients about safe and effective diets?

Dr. Laing: Encourage patients to be skeptical of social media trends that seem too good to be true. Many [social media] creators lack the education or professional credentials to offer sound nutrition advice, and their posts could do harm. Explain that individual nutrition needs differ considerably based on age, activity patterns, health conditions, and medications, and one person’s way of eating or success is often not realistic for someone else.

Encourage open dialogue and provide nonjudgmental advice. If the taste of oatzempic intrigues patients, there is likely no harm in experimenting. Work on ensuring their meals are adequate in calories and contain sources of protein and healthy fats to prevent spikes in blood glucose. It’s crucial to communicate that weight loss doesn’t always equate with improved health.

Sharing information from the Academy of Nutrition and Dietetics and the American Diabetes Association can equip patients with tools they can implement under their clinician’s guidance. A provider’s greatest ally in diabetes care is a registered dietitian nutritionist (RDN) who is a Certified Diabetes Care and Education Specialist. RDNs will determine specific energy and nutrient needs and provide medical nutrition therapy such as carbohydrate counting, simplified meal plans, healthy food choices, exchange lists, and behavior strategies to help patients manage their diabetes. Many insurance plans cover these services.

What additional comments would you like to share with clinicians whose patients may ask them about the oatzempic diet?

Dr. Passerrello: What we do consistently matters. If your patient likes the taste of oatzempic in one meal a day, it’s a way to get more oats into their diet, if they focus their other meals on vegetables, fruits, whole grains, lean protein, and unsaturated fats.

Diets are out, and sustainable dietary patterns are in. Diets are one-size-fits-all, whereas a sustainable dietary pattern is individualized based on a person’s goals, medical history, taste preferences, budget, and lifestyle. Visit MyPlate.gov or work with an RDN [visit https://www.eatright.org/find-a-nutrition-expert to find nutritionists near your patients] to determine what a sustainable dietary pattern looks like.

What do clinicians need to know about claims on social media that a related drink — ‘ricezempic’ — aids weight loss?

Dr. Laing: Ricezempic promoters claim that drinking the beverage — typically made by soaking 1/2 cup of uncooked white rice in 1 cup of water and the juice from half a lime, then discarding the rice and drinking the liquid before breakfast — will lead to weight loss because the strained water provides a small dose of resistant starch, which is a source of prebiotics. Studies have shown that ingesting prebiotics may help lower blood cholesterol, improve blood glucose and insulin sensitivity, and benefit digestive function; however, more research is needed to determine specifics and if prebiotics are proven for weight loss.

Does ricezempic work?

Dr. Laing: There is no evidence that this concoction provides the same outcomes as GLP-1 agonists. The diet and the drug are not similar in mechanism of action or strength of scientific evidence to support their role in diabetes and weight management. Even if ricezempic provides a small amount of resistant starch and hydration from the rice water and citric acid from the lime juice, it is missing fiber, protein, healthy fats, and other vitamins and minerals that enhance the nutrient content of a meal or snack and stabilize blood sugar.

What advice do you have for clinicians whose patients with diabetes ask them about ricezempic?

Dr. Laing: I would not suggest that patients rely on ricezempic to support their health. There is no scientific evidence to show that people will lose weight in the short or long term by drinking ricezempic before a meal (or as a meal replacement).

If your patients are aiming to increase their intake of prebiotics, they are naturally found in various vegetables, fruits, whole grains, and seeds and in yogurt and high-fiber breads and cereals. A nutritious eating pattern that includes these foods is most beneficial for health.

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

A so-called “oatzempic” diet has been bouncing around the internet posing as a cheap — and available — weight loss alternative to Ozempic.

Fans of the diet, made trendy by TikTok postings and a clever name, claim that an oat-based smoothie helps people quickly shed lots of weight. The smoothie is made by blending 1/2 cup of oats, 1 cup of water, a squeeze of lime, and maybe a dash of cinnamon or other flavoring agents, typically as the first meal of the day, often after fasting, followed by normal meals.

Despite the hype, the oatzempic drink is a far cry from Ozempic (semaglutide), the glucagon-like peptide 1 (GLP-1) medication the Food and Drug Administration has approved only for type 2 diabetes management but used off label for weight loss.

So how do pulverized oats stack up against prescription-based GLP-1s? According to two nutrition experts, they’re not as effective as some TikTok influencers claim. And in people with diabetes, the diet can be dangerous.
 

Nutritionists Answer Questions on Oatzempic

Caroline West Passerrello, EdD, RDN, LDN, an instructor and community coordinator in the School of Health and Rehabilitation Sciences at the University of Pittsburgh, Pennsylvania, and Emma Laing, PhD, RDN, LD, a clinical professor and director of dietetics in the College of Family and Consumer Sciences at the University of Georgia, Athens, talked about this fad in emails.

Can the ‘oatzempic’ diet help people lose weight?

Dr. Passerrello: Oats are particularly high in soluble fiber, and high-fiber foods can increase the natural production of GLPs. But studies are mixed on whether this happens when eating oats.

The high content of soluble beta-glucan fiber in oats and the appetite-suppressing citric acid in lime can potentially promote decreased appetite and increased satiety. But a bowl of oatmeal, though not as trendy, will probably produce the same results.

Is the oatzempic diet safe for people with type 2 diabetes?

Dr. Laing: This diet has the potential to cause harm. The diet and the drug are not similar in mechanism of action or strength of scientific evidence to support their role in diabetes and weight management. There is no evidence that this concoction provides the same outcomes as GLP-1 agonists. Rapid weight loss is unsustainable and can be harmful, and frequent spikes in blood sugar can harm adults and children with diabetes. So the oatzempic diet’s safety depends on the rate of weight loss and the effect on blood sugar. While it provides beta-glucan from oats and citric acid from lime juice, it is missing protein, healthy fats, and other vitamins and minerals that enhance the nutrient content and stabilize blood sugar.

Maintaining relatively consistent, normal-range blood glucose concentrations is key for managing diabetes and lowering the risks for other health complications. Carbohydrate sources consumed on their own can produce greater blood sugar fluctuations than when combined with proteins and fats, which slow carbohydrate digestion speed. So pairing oats with fruits, vegetables, healthy fats, and protein sources enhances the flavor, texture, and nutrient composition of the dish and can help slow the postprandial rise in blood glucose.

In the long term, any restrictive fad diet likely cannot be sustained and increases the risk for malnutrition, metabolic rate slowing to conserve energy, depression, social isolation, or eating disorder.

Additional considerations apply to children, with or without diabetes. Restrictive, extreme diets that promise quick results typically “work” by promoting body water and muscle mass losses. Such diets are not only contraindicated in children, who are undergoing rapid growth and development, but also unsustainable and can lead to physical and psychological problems that carry into adulthood.

What strategies and tactics can physicians use to effectively communicate with their patients about safe and effective diets?

Dr. Laing: Encourage patients to be skeptical of social media trends that seem too good to be true. Many [social media] creators lack the education or professional credentials to offer sound nutrition advice, and their posts could do harm. Explain that individual nutrition needs differ considerably based on age, activity patterns, health conditions, and medications, and one person’s way of eating or success is often not realistic for someone else.

Encourage open dialogue and provide nonjudgmental advice. If the taste of oatzempic intrigues patients, there is likely no harm in experimenting. Work on ensuring their meals are adequate in calories and contain sources of protein and healthy fats to prevent spikes in blood glucose. It’s crucial to communicate that weight loss doesn’t always equate with improved health.

Sharing information from the Academy of Nutrition and Dietetics and the American Diabetes Association can equip patients with tools they can implement under their clinician’s guidance. A provider’s greatest ally in diabetes care is a registered dietitian nutritionist (RDN) who is a Certified Diabetes Care and Education Specialist. RDNs will determine specific energy and nutrient needs and provide medical nutrition therapy such as carbohydrate counting, simplified meal plans, healthy food choices, exchange lists, and behavior strategies to help patients manage their diabetes. Many insurance plans cover these services.

What additional comments would you like to share with clinicians whose patients may ask them about the oatzempic diet?

Dr. Passerrello: What we do consistently matters. If your patient likes the taste of oatzempic in one meal a day, it’s a way to get more oats into their diet, if they focus their other meals on vegetables, fruits, whole grains, lean protein, and unsaturated fats.

Diets are out, and sustainable dietary patterns are in. Diets are one-size-fits-all, whereas a sustainable dietary pattern is individualized based on a person’s goals, medical history, taste preferences, budget, and lifestyle. Visit MyPlate.gov or work with an RDN [visit https://www.eatright.org/find-a-nutrition-expert to find nutritionists near your patients] to determine what a sustainable dietary pattern looks like.

What do clinicians need to know about claims on social media that a related drink — ‘ricezempic’ — aids weight loss?

Dr. Laing: Ricezempic promoters claim that drinking the beverage — typically made by soaking 1/2 cup of uncooked white rice in 1 cup of water and the juice from half a lime, then discarding the rice and drinking the liquid before breakfast — will lead to weight loss because the strained water provides a small dose of resistant starch, which is a source of prebiotics. Studies have shown that ingesting prebiotics may help lower blood cholesterol, improve blood glucose and insulin sensitivity, and benefit digestive function; however, more research is needed to determine specifics and if prebiotics are proven for weight loss.

Does ricezempic work?

Dr. Laing: There is no evidence that this concoction provides the same outcomes as GLP-1 agonists. The diet and the drug are not similar in mechanism of action or strength of scientific evidence to support their role in diabetes and weight management. Even if ricezempic provides a small amount of resistant starch and hydration from the rice water and citric acid from the lime juice, it is missing fiber, protein, healthy fats, and other vitamins and minerals that enhance the nutrient content of a meal or snack and stabilize blood sugar.

What advice do you have for clinicians whose patients with diabetes ask them about ricezempic?

Dr. Laing: I would not suggest that patients rely on ricezempic to support their health. There is no scientific evidence to show that people will lose weight in the short or long term by drinking ricezempic before a meal (or as a meal replacement).

If your patients are aiming to increase their intake of prebiotics, they are naturally found in various vegetables, fruits, whole grains, and seeds and in yogurt and high-fiber breads and cereals. A nutritious eating pattern that includes these foods is most beneficial for health.

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

Obesity has now reached epidemic proportions, with global prevalence of the condition increasing more than threefold between 1975 and 2022. In the United States alone, roughly two in five adults have obesity. As healthcare providers are intimately aware, obesity is linked to many serious health conditions, including type 2 diabetes, cardiovascular disease, and metabolic-associated steatotic liver disease, as well as some forms of cancer. As such, it presents a major challenge to chronic disease prevention and overall health.

For many years, management of obesity was considered within the purview of primary care as part of chronic disease management. However, as obesity has become more common, our understanding of the underlying causes of obesity has improved, and optimal strategies to manage and treat obesity have evolved. A new field of obesity medicine has arisen, attracting specialists such as gastroenterologists, surgeons, endocrinologists, and others. From glucagon-like peptide 1 agonists to an expanding armamentarium of bariatric procedures, emerging therapeutics have revolutionized treatment of patients with obesity and related health conditions.

In this month’s Member Spotlight, we introduce you to gastroenterologist Dr. Janese Laster, who has built a successful career with a primary focus on obesity medicine. She shares her passionate perspective on why gastroenterologists should play a more prominent role in management of this complex, chronic disease. We also include a summary of obesity-related content presented as part of this spring’s AGA Post-Graduate Course, with helpful clinical pearls from experts Dr. Andres Acosta, Dr. Violeta Popov, Dr. Sonali Paul, and Dr. Pooja Singhal.

Also in our September issue, we highlight a recent, practice-changing randomized controlled trial from Clinical Gastroenterology and Hepatology supporting use of snare tip soft coagulation as the preferred thermal margin treatment to reduce recurrence rates following colorectal endoscopic mucosal resection. In our quarterly Perspectives column, Dr. Maggie Ham and Dr. Petr Protiva offer their insights into a pressing question on many of our minds — whether to take the 10-year “high-stakes” exam or opt for the Longitudinal Knowledge Assessment to maintain American Board of Internal Medicine certification. As always, thanks for reading and please don’t hesitate to reach out with suggestions for future coverage.

Megan A. Adams, MD, JD, MSc

Editor in Chief

Obesity has now reached epidemic proportions, with global prevalence of the condition increasing more than threefold between 1975 and 2022. In the United States alone, roughly two in five adults have obesity. As healthcare providers are intimately aware, obesity is linked to many serious health conditions, including type 2 diabetes, cardiovascular disease, and metabolic-associated steatotic liver disease, as well as some forms of cancer. As such, it presents a major challenge to chronic disease prevention and overall health.

For many years, management of obesity was considered within the purview of primary care as part of chronic disease management. However, as obesity has become more common, our understanding of the underlying causes of obesity has improved, and optimal strategies to manage and treat obesity have evolved. A new field of obesity medicine has arisen, attracting specialists such as gastroenterologists, surgeons, endocrinologists, and others. From glucagon-like peptide 1 agonists to an expanding armamentarium of bariatric procedures, emerging therapeutics have revolutionized treatment of patients with obesity and related health conditions.

In this month’s Member Spotlight, we introduce you to gastroenterologist Dr. Janese Laster, who has built a successful career with a primary focus on obesity medicine. She shares her passionate perspective on why gastroenterologists should play a more prominent role in management of this complex, chronic disease. We also include a summary of obesity-related content presented as part of this spring’s AGA Post-Graduate Course, with helpful clinical pearls from experts Dr. Andres Acosta, Dr. Violeta Popov, Dr. Sonali Paul, and Dr. Pooja Singhal.

Also in our September issue, we highlight a recent, practice-changing randomized controlled trial from Clinical Gastroenterology and Hepatology supporting use of snare tip soft coagulation as the preferred thermal margin treatment to reduce recurrence rates following colorectal endoscopic mucosal resection. In our quarterly Perspectives column, Dr. Maggie Ham and Dr. Petr Protiva offer their insights into a pressing question on many of our minds — whether to take the 10-year “high-stakes” exam or opt for the Longitudinal Knowledge Assessment to maintain American Board of Internal Medicine certification. As always, thanks for reading and please don’t hesitate to reach out with suggestions for future coverage.

Megan A. Adams, MD, JD, MSc

Editor in Chief

Obesity has now reached epidemic proportions, with global prevalence of the condition increasing more than threefold between 1975 and 2022. In the United States alone, roughly two in five adults have obesity. As healthcare providers are intimately aware, obesity is linked to many serious health conditions, including type 2 diabetes, cardiovascular disease, and metabolic-associated steatotic liver disease, as well as some forms of cancer. As such, it presents a major challenge to chronic disease prevention and overall health.

For many years, management of obesity was considered within the purview of primary care as part of chronic disease management. However, as obesity has become more common, our understanding of the underlying causes of obesity has improved, and optimal strategies to manage and treat obesity have evolved. A new field of obesity medicine has arisen, attracting specialists such as gastroenterologists, surgeons, endocrinologists, and others. From glucagon-like peptide 1 agonists to an expanding armamentarium of bariatric procedures, emerging therapeutics have revolutionized treatment of patients with obesity and related health conditions.

In this month’s Member Spotlight, we introduce you to gastroenterologist Dr. Janese Laster, who has built a successful career with a primary focus on obesity medicine. She shares her passionate perspective on why gastroenterologists should play a more prominent role in management of this complex, chronic disease. We also include a summary of obesity-related content presented as part of this spring’s AGA Post-Graduate Course, with helpful clinical pearls from experts Dr. Andres Acosta, Dr. Violeta Popov, Dr. Sonali Paul, and Dr. Pooja Singhal.

Also in our September issue, we highlight a recent, practice-changing randomized controlled trial from Clinical Gastroenterology and Hepatology supporting use of snare tip soft coagulation as the preferred thermal margin treatment to reduce recurrence rates following colorectal endoscopic mucosal resection. In our quarterly Perspectives column, Dr. Maggie Ham and Dr. Petr Protiva offer their insights into a pressing question on many of our minds — whether to take the 10-year “high-stakes” exam or opt for the Longitudinal Knowledge Assessment to maintain American Board of Internal Medicine certification. As always, thanks for reading and please don’t hesitate to reach out with suggestions for future coverage.

Megan A. Adams, MD, JD, MSc

Editor in Chief

Stigma around obesity can have a crippling effect on patients. Janese Laster, MD, sees the impact of this problem every day.

It takes a long time for some patients with obesity to acknowledge that they need help, said Dr. Laster, a bariatric endoscopist who specializes in gastroenterology, nutrition, and obesity medicine at Gut Theory Total Digestive Care, and Georgetown University Hospital in Washington. “If somebody has high blood pressure or has a cut or has chest pain, you don’t wait for things. You would go seek help immediately. I wish more patients reached out sooner and didn’t struggle.”

Courtesy Dr. Janese Laster

Another big challenge is making sure patients have insurance coverage for things like medications, surgery, and bariatric endoscopy, she added.

Her response: education and advocacy. “I’m giving as many talks as I can to fellows, creating courses for residents and fellows and medical students” to change the way physicians talk about obesity and excess weight, she said. Patients need to understand that physicians care about them, that “we’re not judging and we’re changing that perspective.”

Dr. Laster is also working with members of Congress to get bills passed for coverage of obesity medication and procedures. In an interview with GI & Hepatology News, she spoke more about the intersection between nutrition, medicine and bariatric procedures and the importance of offering patients multiple solutions.
 

Q: Why did you choose GI? 

It allowed me a little bit of everything. You have clinic, where you can really interact with patients and get to the root of their problem. You have preventative care with routine colonoscopies and upper endoscopies to prevent for cancer. But then you also have fun stuff — which my mom told me to stop saying out loud — ‘bleeders’ and acute things that you get to fix immediately. So, you get the adrenaline rush too. I like it because you get the best of all worlds and it’s really hard to get bored.

Q: How did you become interested in nutrition and bariatric endoscopy?

My parents had a garden and never let us eat processed foods. In residency, I kept seeing the same medical problems over and over again. Everybody had high blood pressure, high cholesterol, and diabetes. Then in GI clinic, everybody had abdominal pain, bloating, constipation, heartburn, and a million GI appointments for these same things. Everyone’s upper endoscopy or colonoscopy was negative. Something else had to be going on.

And that’s sort of where it came from; figuring out the common denominator. It had to be what people were eating. There’s also the prevalence of patients with obesity going up every single year. Correlating all these other medical problems with people’s diets led me down the rabbit hole of: What else can we be doing?

Most people don’t want to undergo surgery. Only 2% of people eligible for surgery actually do it, even though it works. The reasons are because it’s invasive or there’s shame behind it. Bariatric endoscopy is another option that’s out here, that’s less invasive. I’m an endoscopist and gastroenterologist. I should be able to offer all those things and I should know more about nutrition. We don’t talk about it enough.
 

Q: Do you think more GI doctors should become better educated about nutrition?

100%. Every patient I see has seen a GI doctor before and says, ‘No one has ever told me that if I have carbonated beverages and cheese every day, I’m going to be bloated and constipated.’ And that shouldn’t be the case.

Q: Why do you think that more GI doctors don’t get the education on nutrition during their medical training?

I think it’s our healthcare system. It’s very much focused on secondary treatment rather than preventative care. There’s no emphasis on preventing things from happening.

We’re really good at reactionary medicine. People who have an ulcer, big polyps and colon cancer, esophageal cancer — we do those things really well. But I think because there’s no ICD-10 codes for preventive care via nutrition education, and no good reimbursement, then there’s no incentive for hospital systems to pay for these things. It’s a system based on RVUs (relative value units) and numbers. That’s been our trajectory. We’ve been so focused on reactionary medicine rather than saying, ‘Okay, let’s stop this from happening.’

We just didn’t talk about nutrition in medical school, in residency, or in fellowship. It was looked at as a soft science. When I was in school, people would also say, ‘No one’s going to change. So it’s a waste of your time essentially to talk to people about making dietary changes.’ I feel like if you give people the opportunity, you have to give them the chance. You can’t just write everybody off. Some people won’t change, but that’s okay. They should at least have the opportunity to do so.
 

Q: How do you determine whether a patient is a good candidate for bariatric surgery?

It’s based on the guidelines: If they meet the BMI requirements, if they have obesity-associated comorbidities, their risk for surgery is low. But it’s also whether they want to do it or not. A patient has to be in the mindset and be ready for it. They need to want to have surgery or bariatric endoscopy, or to use medications, or start to make a change. Some people aren’t there yet — that preemptive stage of making a change. They want the solution, but they’re not ready to do that legwork yet.

And all of it is work. I tell patients, ‘Whether it’s medication or bariatric endoscopy or bariatric surgery, you still have work to do. None of it is going to just magically happen where you could just continue to do the same thing you’re doing now and you’re going to lose weight and keep it off.’
 

Q: What advances in obesity prevention are you excited about?

I’m excited that bariatric endoscopy came about in the first place, because in every other field there are less invasive approaches that have become available. I’m also excited about the emergence of weight loss medication, like GLP-1s. I think they are a tool that we need.

Q: Do you think the weight loss medications may negate the need for surgery?

I don’t think they necessarily reduce the need for surgery. There’s still a lot we don’t know about why they work in some patients and why they don’t work in others.

Some of our colleagues have come up with phenotypes and blood tests so we can better understand which things will work in different patients. Surgery doesn’t work for some patients. People may need a combination of both after they reach a plateau. I’m excited that people see this as something that we should be researching and putting more effort into — that obesity isn’t a disease of moral failure, that people with excess weight just need to ‘move more’ or ‘eat less’ and it’s their fault. I’m glad people are starting to understand that.
 

Q: What teacher or mentor had the greatest impact on you?

Probably two. One of them is Andrea E Reid, MD, MPH, a dean of medicine at Harvard. She gives you such motivation to achieve things, no matter how big your idea is or how crazy it may seem. If you have something that you think is important, you go after it. Another person is Christopher C. Thompson, MD, at Brigham and Women’s Hospital, the father of bariatric endoscopy in a sense. He embodies what Dr. Reid talks about: crazy big ideas. And he goes after them and he succeeds. Having him push me and giving me that type of encouragement was invaluable.

Q: Describe how you would spend a free Saturday afternoon.

Every Saturday is yoga or some type of movement. Spending some time outside doing something, whether it’s messing around with plants that I’m not very good at, or going for a walk.

Lightning Round

Texting or talking?

Text

Favorite city in U.S. besides the one you live in?

New York

Favorite breakfast?

Avocado toast

Place you most want to travel to?

Istanbul

Favorite season?

Fall

Favorite ice cream flavor?

Raspberry sorbet

How many cups of coffee do you drink per day?

One

Best place you ever went on vacation?

Greece

If you weren’t a gastroenterologist, what would you be?

Own a clothing store

Favorite type of music?

Old school R&B

Favorite movie genre?

Romantic comedy or drama

Cat person or dog person?

Dog

Favorite sport?

Football

Favorite holiday?

Christmas

Optimist or pessimist?

Optimist

Stigma around obesity can have a crippling effect on patients. Janese Laster, MD, sees the impact of this problem every day.

It takes a long time for some patients with obesity to acknowledge that they need help, said Dr. Laster, a bariatric endoscopist who specializes in gastroenterology, nutrition, and obesity medicine at Gut Theory Total Digestive Care, and Georgetown University Hospital in Washington. “If somebody has high blood pressure or has a cut or has chest pain, you don’t wait for things. You would go seek help immediately. I wish more patients reached out sooner and didn’t struggle.”

Courtesy Dr. Janese Laster

Another big challenge is making sure patients have insurance coverage for things like medications, surgery, and bariatric endoscopy, she added.

Her response: education and advocacy. “I’m giving as many talks as I can to fellows, creating courses for residents and fellows and medical students” to change the way physicians talk about obesity and excess weight, she said. Patients need to understand that physicians care about them, that “we’re not judging and we’re changing that perspective.”

Dr. Laster is also working with members of Congress to get bills passed for coverage of obesity medication and procedures. In an interview with GI & Hepatology News, she spoke more about the intersection between nutrition, medicine and bariatric procedures and the importance of offering patients multiple solutions.
 

Q: Why did you choose GI? 

It allowed me a little bit of everything. You have clinic, where you can really interact with patients and get to the root of their problem. You have preventative care with routine colonoscopies and upper endoscopies to prevent for cancer. But then you also have fun stuff — which my mom told me to stop saying out loud — ‘bleeders’ and acute things that you get to fix immediately. So, you get the adrenaline rush too. I like it because you get the best of all worlds and it’s really hard to get bored.

Q: How did you become interested in nutrition and bariatric endoscopy?

My parents had a garden and never let us eat processed foods. In residency, I kept seeing the same medical problems over and over again. Everybody had high blood pressure, high cholesterol, and diabetes. Then in GI clinic, everybody had abdominal pain, bloating, constipation, heartburn, and a million GI appointments for these same things. Everyone’s upper endoscopy or colonoscopy was negative. Something else had to be going on.

And that’s sort of where it came from; figuring out the common denominator. It had to be what people were eating. There’s also the prevalence of patients with obesity going up every single year. Correlating all these other medical problems with people’s diets led me down the rabbit hole of: What else can we be doing?

Most people don’t want to undergo surgery. Only 2% of people eligible for surgery actually do it, even though it works. The reasons are because it’s invasive or there’s shame behind it. Bariatric endoscopy is another option that’s out here, that’s less invasive. I’m an endoscopist and gastroenterologist. I should be able to offer all those things and I should know more about nutrition. We don’t talk about it enough.
 

Q: Do you think more GI doctors should become better educated about nutrition?

100%. Every patient I see has seen a GI doctor before and says, ‘No one has ever told me that if I have carbonated beverages and cheese every day, I’m going to be bloated and constipated.’ And that shouldn’t be the case.

Q: Why do you think that more GI doctors don’t get the education on nutrition during their medical training?

I think it’s our healthcare system. It’s very much focused on secondary treatment rather than preventative care. There’s no emphasis on preventing things from happening.

We’re really good at reactionary medicine. People who have an ulcer, big polyps and colon cancer, esophageal cancer — we do those things really well. But I think because there’s no ICD-10 codes for preventive care via nutrition education, and no good reimbursement, then there’s no incentive for hospital systems to pay for these things. It’s a system based on RVUs (relative value units) and numbers. That’s been our trajectory. We’ve been so focused on reactionary medicine rather than saying, ‘Okay, let’s stop this from happening.’

We just didn’t talk about nutrition in medical school, in residency, or in fellowship. It was looked at as a soft science. When I was in school, people would also say, ‘No one’s going to change. So it’s a waste of your time essentially to talk to people about making dietary changes.’ I feel like if you give people the opportunity, you have to give them the chance. You can’t just write everybody off. Some people won’t change, but that’s okay. They should at least have the opportunity to do so.
 

Q: How do you determine whether a patient is a good candidate for bariatric surgery?

It’s based on the guidelines: If they meet the BMI requirements, if they have obesity-associated comorbidities, their risk for surgery is low. But it’s also whether they want to do it or not. A patient has to be in the mindset and be ready for it. They need to want to have surgery or bariatric endoscopy, or to use medications, or start to make a change. Some people aren’t there yet — that preemptive stage of making a change. They want the solution, but they’re not ready to do that legwork yet.

And all of it is work. I tell patients, ‘Whether it’s medication or bariatric endoscopy or bariatric surgery, you still have work to do. None of it is going to just magically happen where you could just continue to do the same thing you’re doing now and you’re going to lose weight and keep it off.’
 

Q: What advances in obesity prevention are you excited about?

I’m excited that bariatric endoscopy came about in the first place, because in every other field there are less invasive approaches that have become available. I’m also excited about the emergence of weight loss medication, like GLP-1s. I think they are a tool that we need.

Q: Do you think the weight loss medications may negate the need for surgery?

I don’t think they necessarily reduce the need for surgery. There’s still a lot we don’t know about why they work in some patients and why they don’t work in others.

Some of our colleagues have come up with phenotypes and blood tests so we can better understand which things will work in different patients. Surgery doesn’t work for some patients. People may need a combination of both after they reach a plateau. I’m excited that people see this as something that we should be researching and putting more effort into — that obesity isn’t a disease of moral failure, that people with excess weight just need to ‘move more’ or ‘eat less’ and it’s their fault. I’m glad people are starting to understand that.
 

Q: What teacher or mentor had the greatest impact on you?

Probably two. One of them is Andrea E Reid, MD, MPH, a dean of medicine at Harvard. She gives you such motivation to achieve things, no matter how big your idea is or how crazy it may seem. If you have something that you think is important, you go after it. Another person is Christopher C. Thompson, MD, at Brigham and Women’s Hospital, the father of bariatric endoscopy in a sense. He embodies what Dr. Reid talks about: crazy big ideas. And he goes after them and he succeeds. Having him push me and giving me that type of encouragement was invaluable.

Q: Describe how you would spend a free Saturday afternoon.

Every Saturday is yoga or some type of movement. Spending some time outside doing something, whether it’s messing around with plants that I’m not very good at, or going for a walk.

Lightning Round

Texting or talking?

Text

Favorite city in U.S. besides the one you live in?

New York

Favorite breakfast?

Avocado toast

Place you most want to travel to?

Istanbul

Favorite season?

Fall

Favorite ice cream flavor?

Raspberry sorbet

How many cups of coffee do you drink per day?

One

Best place you ever went on vacation?

Greece

If you weren’t a gastroenterologist, what would you be?

Own a clothing store

Favorite type of music?

Old school R&B

Favorite movie genre?

Romantic comedy or drama

Cat person or dog person?

Dog

Favorite sport?

Football

Favorite holiday?

Christmas

Optimist or pessimist?

Optimist

Stigma around obesity can have a crippling effect on patients. Janese Laster, MD, sees the impact of this problem every day.

It takes a long time for some patients with obesity to acknowledge that they need help, said Dr. Laster, a bariatric endoscopist who specializes in gastroenterology, nutrition, and obesity medicine at Gut Theory Total Digestive Care, and Georgetown University Hospital in Washington. “If somebody has high blood pressure or has a cut or has chest pain, you don’t wait for things. You would go seek help immediately. I wish more patients reached out sooner and didn’t struggle.”

Courtesy Dr. Janese Laster

Another big challenge is making sure patients have insurance coverage for things like medications, surgery, and bariatric endoscopy, she added.

Her response: education and advocacy. “I’m giving as many talks as I can to fellows, creating courses for residents and fellows and medical students” to change the way physicians talk about obesity and excess weight, she said. Patients need to understand that physicians care about them, that “we’re not judging and we’re changing that perspective.”

Dr. Laster is also working with members of Congress to get bills passed for coverage of obesity medication and procedures. In an interview with GI & Hepatology News, she spoke more about the intersection between nutrition, medicine and bariatric procedures and the importance of offering patients multiple solutions.
 

Q: Why did you choose GI? 

It allowed me a little bit of everything. You have clinic, where you can really interact with patients and get to the root of their problem. You have preventative care with routine colonoscopies and upper endoscopies to prevent for cancer. But then you also have fun stuff — which my mom told me to stop saying out loud — ‘bleeders’ and acute things that you get to fix immediately. So, you get the adrenaline rush too. I like it because you get the best of all worlds and it’s really hard to get bored.

Q: How did you become interested in nutrition and bariatric endoscopy?

My parents had a garden and never let us eat processed foods. In residency, I kept seeing the same medical problems over and over again. Everybody had high blood pressure, high cholesterol, and diabetes. Then in GI clinic, everybody had abdominal pain, bloating, constipation, heartburn, and a million GI appointments for these same things. Everyone’s upper endoscopy or colonoscopy was negative. Something else had to be going on.

And that’s sort of where it came from; figuring out the common denominator. It had to be what people were eating. There’s also the prevalence of patients with obesity going up every single year. Correlating all these other medical problems with people’s diets led me down the rabbit hole of: What else can we be doing?

Most people don’t want to undergo surgery. Only 2% of people eligible for surgery actually do it, even though it works. The reasons are because it’s invasive or there’s shame behind it. Bariatric endoscopy is another option that’s out here, that’s less invasive. I’m an endoscopist and gastroenterologist. I should be able to offer all those things and I should know more about nutrition. We don’t talk about it enough.
 

Q: Do you think more GI doctors should become better educated about nutrition?

100%. Every patient I see has seen a GI doctor before and says, ‘No one has ever told me that if I have carbonated beverages and cheese every day, I’m going to be bloated and constipated.’ And that shouldn’t be the case.

Q: Why do you think that more GI doctors don’t get the education on nutrition during their medical training?

I think it’s our healthcare system. It’s very much focused on secondary treatment rather than preventative care. There’s no emphasis on preventing things from happening.

We’re really good at reactionary medicine. People who have an ulcer, big polyps and colon cancer, esophageal cancer — we do those things really well. But I think because there’s no ICD-10 codes for preventive care via nutrition education, and no good reimbursement, then there’s no incentive for hospital systems to pay for these things. It’s a system based on RVUs (relative value units) and numbers. That’s been our trajectory. We’ve been so focused on reactionary medicine rather than saying, ‘Okay, let’s stop this from happening.’

We just didn’t talk about nutrition in medical school, in residency, or in fellowship. It was looked at as a soft science. When I was in school, people would also say, ‘No one’s going to change. So it’s a waste of your time essentially to talk to people about making dietary changes.’ I feel like if you give people the opportunity, you have to give them the chance. You can’t just write everybody off. Some people won’t change, but that’s okay. They should at least have the opportunity to do so.
 

Q: How do you determine whether a patient is a good candidate for bariatric surgery?

It’s based on the guidelines: If they meet the BMI requirements, if they have obesity-associated comorbidities, their risk for surgery is low. But it’s also whether they want to do it or not. A patient has to be in the mindset and be ready for it. They need to want to have surgery or bariatric endoscopy, or to use medications, or start to make a change. Some people aren’t there yet — that preemptive stage of making a change. They want the solution, but they’re not ready to do that legwork yet.

And all of it is work. I tell patients, ‘Whether it’s medication or bariatric endoscopy or bariatric surgery, you still have work to do. None of it is going to just magically happen where you could just continue to do the same thing you’re doing now and you’re going to lose weight and keep it off.’
 

Q: What advances in obesity prevention are you excited about?

I’m excited that bariatric endoscopy came about in the first place, because in every other field there are less invasive approaches that have become available. I’m also excited about the emergence of weight loss medication, like GLP-1s. I think they are a tool that we need.

Q: Do you think the weight loss medications may negate the need for surgery?

I don’t think they necessarily reduce the need for surgery. There’s still a lot we don’t know about why they work in some patients and why they don’t work in others.

Some of our colleagues have come up with phenotypes and blood tests so we can better understand which things will work in different patients. Surgery doesn’t work for some patients. People may need a combination of both after they reach a plateau. I’m excited that people see this as something that we should be researching and putting more effort into — that obesity isn’t a disease of moral failure, that people with excess weight just need to ‘move more’ or ‘eat less’ and it’s their fault. I’m glad people are starting to understand that.
 

Q: What teacher or mentor had the greatest impact on you?

Probably two. One of them is Andrea E Reid, MD, MPH, a dean of medicine at Harvard. She gives you such motivation to achieve things, no matter how big your idea is or how crazy it may seem. If you have something that you think is important, you go after it. Another person is Christopher C. Thompson, MD, at Brigham and Women’s Hospital, the father of bariatric endoscopy in a sense. He embodies what Dr. Reid talks about: crazy big ideas. And he goes after them and he succeeds. Having him push me and giving me that type of encouragement was invaluable.

Q: Describe how you would spend a free Saturday afternoon.

Every Saturday is yoga or some type of movement. Spending some time outside doing something, whether it’s messing around with plants that I’m not very good at, or going for a walk.

Lightning Round

Texting or talking?

Text

Favorite city in U.S. besides the one you live in?

New York

Favorite breakfast?

Avocado toast

Place you most want to travel to?

Istanbul

Favorite season?

Fall

Favorite ice cream flavor?

Raspberry sorbet

How many cups of coffee do you drink per day?

One

Best place you ever went on vacation?

Greece

If you weren’t a gastroenterologist, what would you be?

Own a clothing store

Favorite type of music?

Old school R&B

Favorite movie genre?

Romantic comedy or drama

Cat person or dog person?

Dog

Favorite sport?

Football

Favorite holiday?

Christmas

Optimist or pessimist?

Optimist

TOPLINE:

A higher intake of lignans (found in plant-based foods such as seeds, whole grains, some fruits and vegetables, and coffee, tea, and cocoa) is linked to a reduced risk for type 2 diabetes (T2D), especially in individuals with obesity or premenopausal women.

METHODOLOGY:

• Lignans, polyphenolic compounds abundant in plant-based foods, are the primary dietary source of phytoestrogens in Western diets and are associated with a reduced risk for cardiometabolic conditions, but the relative associations of individual lignans with T2D are unknown.
• Researchers assessed the associations between the risk for T2D and the intake of total and four primary lignans using the data of 201,111 participants (mean age, 44.7 years; 80.2% women; 96.7% White individuals) from three large prospective US cohorts with over 30 years of follow-up, as well as the association between lignan intake and hemoglobin A1c in 496 participants from the Men’s Lifestyle Validation Study (MLVS).
• For the three large cohorts, lignan intake (total, secoisolariciresinol, matairesinol, pinoresinol, and lariciresinol) was assessed using a validated food frequency questionnaire updated every 2-4 years and categorized into quintiles. For MLVS, diet was assessed by two sets of 7-day diet records and presented as percentage changes in A1c for linear increases in lignan intake.
• Incident T2D was confirmed using diagnostic tests, symptoms, hypoglycemic medication, elevated glucose by several measures.

TAKEAWAY:

• Across the three cohorts, 20,291 cases of T2D were recorded in the full follow-up.
• Higher intakes of total and individual ligands, except for lariciresinol, were associated with about 8%-27% lower T2D incidents (approximate hazard ratio [HR], 0.72-0.93)
• Of the individual lignans, secoisolariciresinol (but not others) showed a significant inverse association with the risk for T2D among those with a body mass index ≥ 30 (HR, 0.75; 95% CI, 0.71-0.79) and premenopausal women (HR, 0.67; 95% CI, 0.65-0.69).
• The dietary intake of lignans assessed using the 7-day diet records in MLVS was associated with lower levels of A1c (percentage changes ranging from −0.92% to −1.50%.

IN PRACTICE:

“Our findings underscore the importance of a healthy plant-based diet rich in lignan-containing foods, including flaxseed products, whole grains, and coffee for the primary prevention of T2D,” the authors wrote.

SOURCE:

The study, led by Siyue Wang, PhD, Department of Nutrition, Harvard TH Chan School of Public Health, Boston, Massachusetts, and the School of Public Health, Peking University, Beijing, China, was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations include the potential for measurement errors in dietary assessments. Flax seed, the most concentrated source of lignans, was not assessed until midway through the three large cohort follow-ups, and this may have resulted in misclassification of the intake levels of secoisolariciresinol. The lack of diversity in the socioeconomic status and race within the population may restrict the generalizability of the findings. Despite making multivariable adjustments, residual confounding cannot be fully ruled out.

DISCLOSURES:

The three cohort studies were supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A higher intake of lignans (found in plant-based foods such as seeds, whole grains, some fruits and vegetables, and coffee, tea, and cocoa) is linked to a reduced risk for type 2 diabetes (T2D), especially in individuals with obesity or premenopausal women.

METHODOLOGY:

• Lignans, polyphenolic compounds abundant in plant-based foods, are the primary dietary source of phytoestrogens in Western diets and are associated with a reduced risk for cardiometabolic conditions, but the relative associations of individual lignans with T2D are unknown.
• Researchers assessed the associations between the risk for T2D and the intake of total and four primary lignans using the data of 201,111 participants (mean age, 44.7 years; 80.2% women; 96.7% White individuals) from three large prospective US cohorts with over 30 years of follow-up, as well as the association between lignan intake and hemoglobin A1c in 496 participants from the Men’s Lifestyle Validation Study (MLVS).
• For the three large cohorts, lignan intake (total, secoisolariciresinol, matairesinol, pinoresinol, and lariciresinol) was assessed using a validated food frequency questionnaire updated every 2-4 years and categorized into quintiles. For MLVS, diet was assessed by two sets of 7-day diet records and presented as percentage changes in A1c for linear increases in lignan intake.
• Incident T2D was confirmed using diagnostic tests, symptoms, hypoglycemic medication, elevated glucose by several measures.

TAKEAWAY:

• Across the three cohorts, 20,291 cases of T2D were recorded in the full follow-up.
• Higher intakes of total and individual ligands, except for lariciresinol, were associated with about 8%-27% lower T2D incidents (approximate hazard ratio [HR], 0.72-0.93)
• Of the individual lignans, secoisolariciresinol (but not others) showed a significant inverse association with the risk for T2D among those with a body mass index ≥ 30 (HR, 0.75; 95% CI, 0.71-0.79) and premenopausal women (HR, 0.67; 95% CI, 0.65-0.69).
• The dietary intake of lignans assessed using the 7-day diet records in MLVS was associated with lower levels of A1c (percentage changes ranging from −0.92% to −1.50%.

IN PRACTICE:

“Our findings underscore the importance of a healthy plant-based diet rich in lignan-containing foods, including flaxseed products, whole grains, and coffee for the primary prevention of T2D,” the authors wrote.

SOURCE:

The study, led by Siyue Wang, PhD, Department of Nutrition, Harvard TH Chan School of Public Health, Boston, Massachusetts, and the School of Public Health, Peking University, Beijing, China, was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations include the potential for measurement errors in dietary assessments. Flax seed, the most concentrated source of lignans, was not assessed until midway through the three large cohort follow-ups, and this may have resulted in misclassification of the intake levels of secoisolariciresinol. The lack of diversity in the socioeconomic status and race within the population may restrict the generalizability of the findings. Despite making multivariable adjustments, residual confounding cannot be fully ruled out.

DISCLOSURES:

The three cohort studies were supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A higher intake of lignans (found in plant-based foods such as seeds, whole grains, some fruits and vegetables, and coffee, tea, and cocoa) is linked to a reduced risk for type 2 diabetes (T2D), especially in individuals with obesity or premenopausal women.

METHODOLOGY:

• Lignans, polyphenolic compounds abundant in plant-based foods, are the primary dietary source of phytoestrogens in Western diets and are associated with a reduced risk for cardiometabolic conditions, but the relative associations of individual lignans with T2D are unknown.
• Researchers assessed the associations between the risk for T2D and the intake of total and four primary lignans using the data of 201,111 participants (mean age, 44.7 years; 80.2% women; 96.7% White individuals) from three large prospective US cohorts with over 30 years of follow-up, as well as the association between lignan intake and hemoglobin A1c in 496 participants from the Men’s Lifestyle Validation Study (MLVS).
• For the three large cohorts, lignan intake (total, secoisolariciresinol, matairesinol, pinoresinol, and lariciresinol) was assessed using a validated food frequency questionnaire updated every 2-4 years and categorized into quintiles. For MLVS, diet was assessed by two sets of 7-day diet records and presented as percentage changes in A1c for linear increases in lignan intake.
• Incident T2D was confirmed using diagnostic tests, symptoms, hypoglycemic medication, elevated glucose by several measures.

TAKEAWAY:

• Across the three cohorts, 20,291 cases of T2D were recorded in the full follow-up.
• Higher intakes of total and individual ligands, except for lariciresinol, were associated with about 8%-27% lower T2D incidents (approximate hazard ratio [HR], 0.72-0.93)
• Of the individual lignans, secoisolariciresinol (but not others) showed a significant inverse association with the risk for T2D among those with a body mass index ≥ 30 (HR, 0.75; 95% CI, 0.71-0.79) and premenopausal women (HR, 0.67; 95% CI, 0.65-0.69).
• The dietary intake of lignans assessed using the 7-day diet records in MLVS was associated with lower levels of A1c (percentage changes ranging from −0.92% to −1.50%.

IN PRACTICE:

“Our findings underscore the importance of a healthy plant-based diet rich in lignan-containing foods, including flaxseed products, whole grains, and coffee for the primary prevention of T2D,” the authors wrote.

SOURCE:

The study, led by Siyue Wang, PhD, Department of Nutrition, Harvard TH Chan School of Public Health, Boston, Massachusetts, and the School of Public Health, Peking University, Beijing, China, was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations include the potential for measurement errors in dietary assessments. Flax seed, the most concentrated source of lignans, was not assessed until midway through the three large cohort follow-ups, and this may have resulted in misclassification of the intake levels of secoisolariciresinol. The lack of diversity in the socioeconomic status and race within the population may restrict the generalizability of the findings. Despite making multivariable adjustments, residual confounding cannot be fully ruled out.

DISCLOSURES:

The three cohort studies were supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

When starting a regular exercise program, the skeletal muscle of sedentary men and women with overweight and obesity differs in burning sugar and fatty acids, but regular training can lessen these differences and promote similar positive metabolic changes in both biological sexes.

METHODOLOGY:

• By stimulating skeletal muscle, exercise can help prevent muscle loss associated with weight loss and improve insulin sensitivity and glucose control in type 2 diabetes, but biological sex-based differences have been reported for many measures.
• This study of sedentary men and women evaluated the molecular differences in skeletal muscle in response to a training program.
• Researchers collected muscle biopsies from 16 women and nine men with overweight or obesity (average age, 30 years) at three time points — baseline, after the first exercise session, and after the last session at the end of training.
• Training involved 1 hour of moderate to intense endurance exercise under supervision (30 minutes cycling on an ergometer and 30 minutes walking on a treadmill) thrice a week for 8 weeks.
• The biopsies were profiled for patterns of three sets of omics data — DNA methylation for insight into genes switched on and off (epigenomics), RNA molecules transcribed from genes (transcriptomics), and proteins (proteomics).

TAKEAWAY:

• At baseline, sex-specific differences were observed most tellingly in 120 proteins and also in DNA methylation sites of 16,012 genes and in 1366 RNA transcripts.
• Men displayed a higher abundance of glycolysis-related proteins and other fast-twitch fiber–type proteins, which are involved in the processing of glucose, while women showed more proteins responsible for regulating fatty acid metabolism.
• The response to the first exercise session differed between men and women, with the cellular stress response upregulated predominantly in men.
• The 8-week exercise training mitigated these sex-specific differences in the skeletal muscle, leading to an upregulation of mitochondrial proteins responsible for substrate oxidation and ATP generation in both men and women.

IN PRACTICE:

“This is important because the increased capacity after exercise to use glucose and lipids for energy production is generally regarded as key to prevent type 2 diabetes,” study leader Professor Cora Weigert from the University of Tübingen, Germany, said in a news release from the meeting organizers. “While initial response of skeletal muscles to exercise differs between females and males, repeated exercise appears to cancel out these differences and trigger beneficial metabolic changes in both sexes,” she added.

SOURCE:

The study was led by Simon I. Dreher, PhD, Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, Tübingen, Germany. It was published on August 15, 2024, as an early release from the annual meeting of the European Association for the Study of Diabetes 2024, Madrid, September 9-13.

LIMITATIONS:

This abstract did not discuss any limitations.

DISCLOSURES:

The authors did not disclose any funding information. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

When starting a regular exercise program, the skeletal muscle of sedentary men and women with overweight and obesity differs in burning sugar and fatty acids, but regular training can lessen these differences and promote similar positive metabolic changes in both biological sexes.

METHODOLOGY:

• By stimulating skeletal muscle, exercise can help prevent muscle loss associated with weight loss and improve insulin sensitivity and glucose control in type 2 diabetes, but biological sex-based differences have been reported for many measures.
• This study of sedentary men and women evaluated the molecular differences in skeletal muscle in response to a training program.
• Researchers collected muscle biopsies from 16 women and nine men with overweight or obesity (average age, 30 years) at three time points — baseline, after the first exercise session, and after the last session at the end of training.
• Training involved 1 hour of moderate to intense endurance exercise under supervision (30 minutes cycling on an ergometer and 30 minutes walking on a treadmill) thrice a week for 8 weeks.
• The biopsies were profiled for patterns of three sets of omics data — DNA methylation for insight into genes switched on and off (epigenomics), RNA molecules transcribed from genes (transcriptomics), and proteins (proteomics).

TAKEAWAY:

• At baseline, sex-specific differences were observed most tellingly in 120 proteins and also in DNA methylation sites of 16,012 genes and in 1366 RNA transcripts.
• Men displayed a higher abundance of glycolysis-related proteins and other fast-twitch fiber–type proteins, which are involved in the processing of glucose, while women showed more proteins responsible for regulating fatty acid metabolism.
• The response to the first exercise session differed between men and women, with the cellular stress response upregulated predominantly in men.
• The 8-week exercise training mitigated these sex-specific differences in the skeletal muscle, leading to an upregulation of mitochondrial proteins responsible for substrate oxidation and ATP generation in both men and women.

IN PRACTICE:

“This is important because the increased capacity after exercise to use glucose and lipids for energy production is generally regarded as key to prevent type 2 diabetes,” study leader Professor Cora Weigert from the University of Tübingen, Germany, said in a news release from the meeting organizers. “While initial response of skeletal muscles to exercise differs between females and males, repeated exercise appears to cancel out these differences and trigger beneficial metabolic changes in both sexes,” she added.

SOURCE:

The study was led by Simon I. Dreher, PhD, Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, Tübingen, Germany. It was published on August 15, 2024, as an early release from the annual meeting of the European Association for the Study of Diabetes 2024, Madrid, September 9-13.

LIMITATIONS:

This abstract did not discuss any limitations.

DISCLOSURES:

The authors did not disclose any funding information. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

When starting a regular exercise program, the skeletal muscle of sedentary men and women with overweight and obesity differs in burning sugar and fatty acids, but regular training can lessen these differences and promote similar positive metabolic changes in both biological sexes.

METHODOLOGY:

• By stimulating skeletal muscle, exercise can help prevent muscle loss associated with weight loss and improve insulin sensitivity and glucose control in type 2 diabetes, but biological sex-based differences have been reported for many measures.
• This study of sedentary men and women evaluated the molecular differences in skeletal muscle in response to a training program.
• Researchers collected muscle biopsies from 16 women and nine men with overweight or obesity (average age, 30 years) at three time points — baseline, after the first exercise session, and after the last session at the end of training.
• Training involved 1 hour of moderate to intense endurance exercise under supervision (30 minutes cycling on an ergometer and 30 minutes walking on a treadmill) thrice a week for 8 weeks.
• The biopsies were profiled for patterns of three sets of omics data — DNA methylation for insight into genes switched on and off (epigenomics), RNA molecules transcribed from genes (transcriptomics), and proteins (proteomics).

TAKEAWAY:

• At baseline, sex-specific differences were observed most tellingly in 120 proteins and also in DNA methylation sites of 16,012 genes and in 1366 RNA transcripts.
• Men displayed a higher abundance of glycolysis-related proteins and other fast-twitch fiber–type proteins, which are involved in the processing of glucose, while women showed more proteins responsible for regulating fatty acid metabolism.
• The response to the first exercise session differed between men and women, with the cellular stress response upregulated predominantly in men.
• The 8-week exercise training mitigated these sex-specific differences in the skeletal muscle, leading to an upregulation of mitochondrial proteins responsible for substrate oxidation and ATP generation in both men and women.

IN PRACTICE:

“This is important because the increased capacity after exercise to use glucose and lipids for energy production is generally regarded as key to prevent type 2 diabetes,” study leader Professor Cora Weigert from the University of Tübingen, Germany, said in a news release from the meeting organizers. “While initial response of skeletal muscles to exercise differs between females and males, repeated exercise appears to cancel out these differences and trigger beneficial metabolic changes in both sexes,” she added.

SOURCE:

The study was led by Simon I. Dreher, PhD, Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, Tübingen, Germany. It was published on August 15, 2024, as an early release from the annual meeting of the European Association for the Study of Diabetes 2024, Madrid, September 9-13.

LIMITATIONS:

This abstract did not discuss any limitations.

DISCLOSURES:

The authors did not disclose any funding information. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Intermittent energy restriction (IER) and continuous energy restriction (CER) reduced body mass index (BMI) in adolescents with obesity after 52 weeks, with no major differences found in body composition or cardiometabolic outcomes.

METHODOLOGY:

• Researchers conducted a 52-week randomized clinical trial at two pediatric centers in Australia that involved 141 adolescents aged 13-17 years with obesity and at least one associated complication.
• Participants were divided into two groups: IER and CER, with three phases: Very low-energy diet (weeks 0-4), intensive intervention (weeks 5-16), and continued intervention/maintenance (weeks 17-52).
• Interventions included a very low-energy diet of 3350 kJ/d (800 kcal/d) for the first 4 weeks, followed by either IER intervention (2500-2950 kJ [600-700 kcal 3 days/wk]) or a daily CER intervention (6000-8000 kJ/d based on age; 1430-1670 kcal/d for teens aged 13-14 years and 1670-1900 kcal/d for teens aged 15-17 years).
• Participants were provided with multivitamins and met with dietitians regularly, with additional support via telephone, text message, or email.

TAKEAWAY:

• Teens in both the IER and CER groups showed a 0.28 reduction in BMI z-scores at 52 weeks with no significant differences between the two.
• The researchers observed no differences in body composition or cardiometabolic outcomes between the IER and CER groups.
• The occurrence of insulin resistance was reduced in both groups at week 16, but this effect was maintained only in the CER group at week 52.
• The study found no significant differences in the occurrence of dyslipidemia or impaired hepatic function between the IER and CER groups.

IN PRACTICE:

“These findings suggest that for adolescents with obesity-associated complications, IER can be incorporated into a behavioral weight management program, providing an option in addition to CER and offering participants more choice,” the authors of the study wrote.

SOURCE:

The study was led by Natalie B. Lister, PhD, of the University of Sydney in Australia and was published online in JAMA Pediatrics.

LIMITATIONS:

The COVID-19 pandemic and subsequent lockdowns limited the sample size. Some dietitian visits were conducted via telehealth.

DISCLOSURES:

Dr. Lister received grants from the National Health and Medical Research Council of Australia. A coauthor, Louise A. Baur, MBBS, PhD, received speakers’ fees from Novo Nordisk and served as a member of the Eli Lilly Advisory Committee.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Intermittent energy restriction (IER) and continuous energy restriction (CER) reduced body mass index (BMI) in adolescents with obesity after 52 weeks, with no major differences found in body composition or cardiometabolic outcomes.

METHODOLOGY:

• Researchers conducted a 52-week randomized clinical trial at two pediatric centers in Australia that involved 141 adolescents aged 13-17 years with obesity and at least one associated complication.
• Participants were divided into two groups: IER and CER, with three phases: Very low-energy diet (weeks 0-4), intensive intervention (weeks 5-16), and continued intervention/maintenance (weeks 17-52).
• Interventions included a very low-energy diet of 3350 kJ/d (800 kcal/d) for the first 4 weeks, followed by either IER intervention (2500-2950 kJ [600-700 kcal 3 days/wk]) or a daily CER intervention (6000-8000 kJ/d based on age; 1430-1670 kcal/d for teens aged 13-14 years and 1670-1900 kcal/d for teens aged 15-17 years).
• Participants were provided with multivitamins and met with dietitians regularly, with additional support via telephone, text message, or email.

TAKEAWAY:

• Teens in both the IER and CER groups showed a 0.28 reduction in BMI z-scores at 52 weeks with no significant differences between the two.
• The researchers observed no differences in body composition or cardiometabolic outcomes between the IER and CER groups.
• The occurrence of insulin resistance was reduced in both groups at week 16, but this effect was maintained only in the CER group at week 52.
• The study found no significant differences in the occurrence of dyslipidemia or impaired hepatic function between the IER and CER groups.

IN PRACTICE:

“These findings suggest that for adolescents with obesity-associated complications, IER can be incorporated into a behavioral weight management program, providing an option in addition to CER and offering participants more choice,” the authors of the study wrote.

SOURCE:

The study was led by Natalie B. Lister, PhD, of the University of Sydney in Australia and was published online in JAMA Pediatrics.

LIMITATIONS:

The COVID-19 pandemic and subsequent lockdowns limited the sample size. Some dietitian visits were conducted via telehealth.

DISCLOSURES:

Dr. Lister received grants from the National Health and Medical Research Council of Australia. A coauthor, Louise A. Baur, MBBS, PhD, received speakers’ fees from Novo Nordisk and served as a member of the Eli Lilly Advisory Committee.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Intermittent energy restriction (IER) and continuous energy restriction (CER) reduced body mass index (BMI) in adolescents with obesity after 52 weeks, with no major differences found in body composition or cardiometabolic outcomes.

METHODOLOGY:

• Researchers conducted a 52-week randomized clinical trial at two pediatric centers in Australia that involved 141 adolescents aged 13-17 years with obesity and at least one associated complication.
• Participants were divided into two groups: IER and CER, with three phases: Very low-energy diet (weeks 0-4), intensive intervention (weeks 5-16), and continued intervention/maintenance (weeks 17-52).
• Interventions included a very low-energy diet of 3350 kJ/d (800 kcal/d) for the first 4 weeks, followed by either IER intervention (2500-2950 kJ [600-700 kcal 3 days/wk]) or a daily CER intervention (6000-8000 kJ/d based on age; 1430-1670 kcal/d for teens aged 13-14 years and 1670-1900 kcal/d for teens aged 15-17 years).
• Participants were provided with multivitamins and met with dietitians regularly, with additional support via telephone, text message, or email.

TAKEAWAY:

• Teens in both the IER and CER groups showed a 0.28 reduction in BMI z-scores at 52 weeks with no significant differences between the two.
• The researchers observed no differences in body composition or cardiometabolic outcomes between the IER and CER groups.
• The occurrence of insulin resistance was reduced in both groups at week 16, but this effect was maintained only in the CER group at week 52.
• The study found no significant differences in the occurrence of dyslipidemia or impaired hepatic function between the IER and CER groups.

IN PRACTICE:

“These findings suggest that for adolescents with obesity-associated complications, IER can be incorporated into a behavioral weight management program, providing an option in addition to CER and offering participants more choice,” the authors of the study wrote.

SOURCE:

The study was led by Natalie B. Lister, PhD, of the University of Sydney in Australia and was published online in JAMA Pediatrics.

LIMITATIONS:

The COVID-19 pandemic and subsequent lockdowns limited the sample size. Some dietitian visits were conducted via telehealth.

DISCLOSURES:

Dr. Lister received grants from the National Health and Medical Research Council of Australia. A coauthor, Louise A. Baur, MBBS, PhD, received speakers’ fees from Novo Nordisk and served as a member of the Eli Lilly Advisory Committee.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.