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RYGB superior to lifestyle-medical intervention alone for diabetes treatment
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Improvements in diabetes treatment goals are greater with Roux-en-Y gastric bypass compared with a lifestyle-medical intervention.
However, Roux-en-Y gastric bypass (RYGB) results in more adverse events, and cardiometabolic effects diminish over time, according to the researchers.
Sayeed Ikramuddin, MD, MHA, professor in the department of surgery and executive medical director of perioperative surgical services at the University of Minnesota in Minneapolis, and colleagues evaluated data from 120 adults (BMI, 30-39.9 kg/m2; HbA1c, 8%) randomly assigned to lifestyle-medical management intervention (n = 60) or lifestyle-medical management intervention with RYGB (n = 60) between April 2008 and December 2011. The lifestyle intervention was based on protocols from the Diabetes Prevention Program and the Look AHEAD study. Participants underwent the intensive behavioral and medical management intervention for 2 years and were followed for an additional 3 years and received standard medical care.
Sayeed Ikramuddin
The primary outcome was met if participants reached the composite endpoint of the American Diabetes Association recommendations of HbA1c less than 7%, LDL cholesterol less than 100 mg/dL and systolic blood pressure less than 130 mm Hg. Durability of the triple endpoint and continuous measures of HbA1c, LDL cholesterol and systolic BP, weight loss, HDL cholesterol, diastolic BP, medication use and adverse events were included in the secondary outcomes.
Full diabetes remission at the 3-year visit was defined as HbA1c less than 6% at 24 and 36 months and no use of antihyperglycemic medication from 24 to 36 months; partial remission was defined as HbA1c less than 6.5% at the same visits without antihyperglycemic medication use and not meeting criteria for full remission.
More participants in the RYGB group met the triple composite endpoint (28%) compared with the intervention-only group (9%; P < .001). HbA1c less than 7% and systolic BP less than 130 mm Hg were achieved by more of the RYGB group (HbA1c, 58%; systolic BP, 72%) compared with the intervention-only group (HbA1c, 22%; systolic BP, 50%).
Thirty-six percent of the RYGB group reached either partial or complete diabetes remission (17% full remission; 19% partial remission), whereas none of the intervention-only group reached diabetes remission.
“Gastric bypass exerts most of its triple endpoint benefit by significantly improving glycemic control, with modest effect on blood pressure and no effect on LDL cholesterol,” the researchers wrote. “Overall, at 3 years, gastric bypass produced a significant and sustained weight loss and significantly improved glycemic control, but a minority of participants received the benefit of triple endpoint attainment or remission of diabetes. Benefits of gastric bypass in management of type 2 diabetes are mainly on improved blood glucose, offset by a higher rate of adverse events.”
Disclosure: Ikramuddin reports various financial ties with Covidien, EnteroMedics, Medica, Metamodix, Novo Nordisk, ReShape Medical and USGI Medical.
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