CHICAGO, IL—Obese patients with Type 2 diabetes who don't have excessive surgical risk may find that Roux-en-Y gastric bypass (RYGB) surgery can help them reduce their risk of heart disease, a new clinical trial shows. The results were presented Tuesday at ICE/ENDO 2014, the joint meeting of the International Society of Endocrinology and the Endocrine Society in Chicago.
"There is emerging evidence highlighting the potential health benefits of bariatric surgery in managing obese patients with Type 2 diabetes. In the past, lifestyle advice and medications provided the mainstay of treatment for this group of patients, but despite the substantial improvements in pharmacotherapy for adults with Type 2 diabetes, many patients still do not achieve targeted health goals," said lead author Su Ann Ding, MBBS, a research fellow at Joslin Diabetes Center in Boston, Massachusetts.
"Roux-en-Y gastric bypass surgery is an acceptable therapeutic option for risk reduction in heart disease in obese patients with Type 2 diabetes in whom surgical risk is not excessive," she said.
To compare the benefits of RYGB surgery with lifestyle and medication modification in these patients, the researchers conducted the randomized prospective SLIMM-T2D clinical trial in Boston.
They recruited 38 obese patients between 21 and 65 years of age who had at least one year of established Type 2 diabetes, a body mass index between 30 and 42 kg/m2, a strong desire for substantial weight loss and a commitment to life-long medical and nutritional follow up. The study participants did not have active cardiovascular or other diseases that would prevent them from exercising safely or undergoing a bariatric surgical procedure and had not smoked for over two months.
The researchers randomly assigned all patients to either have Roux-en-Y gastric bypass surgery at Brigham and Women's Hospital, or to take part in a medical diabetes and weight management program at the Joslin Diabetes Center.
Patients in the medical treatment group enrolled in Joslin's comprehensive Weight Achievement and Intensive Treatment (Why WAIT) program, and worked with an endocrinologist, a registered dietician, an exercise physiologist, a mental health provider, and a certified diabetes nurse educator. For the first 12 weeks, they took part in two-hour weekly group sessions and they followed this with monthly individual counseling.
Patients in both groups lost significant weight and kept it off for 2 years, but the surgical group lost more. The Roux-en-Y group lost roughly 57 pounds on average (25% of their initial body weight) compared with the lifestyle and medication modification group's 13 pounds (6% of their initial body weight). The surgical group also showed better improvements in blood sugar control, blood pressure and cholesterol levels, all of which helped them reduce their risk of developing coronary heart disease.
National Institute of Diabetes and Digestive and Kidney Diseases, a branch of the National Institute of Health principally supported the trial. Covidien; Lifescan, a Division of Johnson & Johnson; Nestlé Nutrition, Inc.; Novo Nordisk; and Mercodia provided additional support.
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