Bariatric Surgery May Free Overweight/Obese Indians From Diabetes

Marlene Busko

June 22, 2016

NEW ORLEANS — In the Comparison of Surgery vs Medicine for Indian Diabetes (COSMID) study of Asian Indians with type 2 diabetes who were mainly below guideline-recommended body mass index (BMI) levels for bariatric surgery, Roux-en-Y gastric bypass led to diabetes remission more than half of the time.

The trial randomized 80 Asian Indians with type 2 diabetes who mostly had a BMI of 25 to 35 kg/m2 to receive Roux-en-Y gastric bypass surgery or an intensive lifestyle-and-medication intervention.

Two years later, 60% of the patients in the bariatric-surgery group vs only 2.5% of patients in the lifestyle-intervention group had diabetes remission (an HbA1c < 6.5% with no diabetes medications).

Shashank S Shah, MD, a bariatric surgeon at the Laparo Obeso Centre in Pune, India, presented the findings from COSMID at the American Diabetes Association (ADA) 2016 Scientific Sessions last week, where he was awarded ADA's 2016 Vivian Fonseca Scholar Award for this research involving minorities.

The COSMID population reflects the diabetic population in India, where people develop type 2 diabetes at a lower BMI and have a larger deposit of visceral fat than people in Western societies, according to Dr Shah.

The study showed for the first time that the diabetes remission and weight-loss benefits of metabolic surgery for South Asians with type 2 diabetes appear to be similar to those reported in studies of more obese patients of predominantly European ethnicity, he said.

The results suggest that "gastric bypass is a metabolic surgery that offers a powerful treatment option, in tandem with lifestyle intervention…for millions of patients [with type 2 diabetes] who otherwise…would not qualify for bariatric surgery based on their BMI," he added.

The main takeaway message is that overweight and obese South Asian patients in COSMID had similar benefits from bariatric surgery as heavier patients of European ethnicity, agreed session moderator Frederico GS Toledo, MD, associate professor of medicine at University of Pittsburgh, Pennsylvania. "Overweight for [patients in India] is sort of the equivalent of obese for us in Western countries," he told Medscape Medical News.

Diabetes Common in India, Occurs at Lower BMI

About 400 million people around the world have diabetes and about a quarter of them live in South Asia (mainly India, as well as Pakistan, Bangladesh, Sri Lanka, Nepal, Afghanistan, Bhutan, and the Maldives), and these numbers are expected to double by 2040, said Dr Shah.

"It is stated that every 10 seconds a patient dies of type 2 diabetes in India, so it's a huge challenge," he noted.

Other studies have reported that bariatric surgery was more effective than lifestyle intervention for weight loss and glycemic control after 1 to 5 years, but they included very few patients with lower BMIs.

Previously, the same researchers performed a pilot study in patients from India with uncontrolled type 2 diabetes and a BMI of 22 to 35 who had gastric-bypass surgery; 9 months later, on average, the patients' HbA1c dropped from 10.1% to 6.1% and they were no longer taking antiglycemic agents.

In COSMID, Dr Shah and colleagues screened 1510 patients — of whom 529 were unwilling to be randomized; 490 were judged unlikely to attend follow-up; 312 had a BMI below 25; and 99 had C-peptide levels that were too low or they were positive for anti-GAD or anti-IA2 antibodies.

They thus randomized 80 patients with type 2 diabetes (who were taking more than two oral antidiabetic medications at more than half maximum dose or were receiving insulin and had an HbA1c > 7.0%) and a BMI of 25 to 40 kg/m2.

The patients had a mean age of 49, and about half were men. They had a mean HbA1c of about 9.5% and had had diabetes for about 5 years.

Almost all the patients (85%) had a BMI below 35, which is the guideline-recommended lower limit, based on studies with predominantly white patients, Dr Shah noted. A group of international experts, who are backed by diabetes organizations, has also recently recommended that bariatric surgery be an option for those with type 2 diabetes and a BMI of 30 to 35.

In COSMID, 49% of the patients had a BMI of 25 to 30; 36% had a BMI 30 to 35, and only 15% had a BMI of 35 to 40.

Forty patients received Roux-en-Y gastric bypass and standard postoperative care that consisted of dietary advice and encouragement to be more physically active.

The other 40 patients received a range of free intensive lifestyle-and-medication interventions: monthly face-to-face counseling sessions, exercise advice, a gym membership, advice from a nutritionist, and access to weight-loss medications (orlistat and/or liraglutide).

Gastric Bypass Works in This Population, but Is It Cost-effective?

In the surgical group, HbA1c dropped drastically from 9.5% to almost normal by 3 months, and it stayed at that level for 2 years. In contrast, in the lifestyle-intervention group, HbA1C dropped from 9.5% to 8.0% and stayed around that level.

"Interestingly, medication usage was reduced in the medication-and-lifestyle intervention group, which does support the benefits of an excellent lifestyle (diet and exercise)," Dr Shah noted. However, the drop in medication use was greater in the surgical group. By 2 years, only 40% of patients in that group were taking diabetes medications.

Patients in the lifestyle-intervention group initially lost weight but this was not sustained. Patients in the surgery group initially lost far more weight, which declined a bit more over the 2 years.

Patients who had the gastric-bypass surgery also lost more inches around the waist and had improved blood pressure and HDL-cholesterol and triglyceride levels.

LDL cholesterol and total cholesterol dropped more in the patients in the lifestyle-and-medication intervention group, but these patients were more likely to be taking a lipid-lowering medication.

A member of the audience wanted to know if the surgery was cost-effective in this patient population.

Dr Shah replied, "I would say that this is the first evidence that gastric bypass does work and has a powerful action in this subset of patients," but this cohort was too small to do a cost analysis.

COSMID was funded by Ethicon, a subsidiary of Johnson & Johnson. Dr Shah is a consultant for Ethicon; disclosures for the coauthors are listed in the abstract.

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American Diabetes Association 2016 Scientific Sessions; June 12, 2016; New Orleans, Louisiana. Abstract 261-OR


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