OBJECTIVE We compared 3-year achievement of an American Diabetes Association composite treatment goal (HbA1c <7.0%, LDL cholesterol <100 mg/dL, and systolic blood pressure <130 mmHg) after 2 years of intensive lifestyle-medical management intervention, with and without Roux-en-Y gastric bypass, with one additional year of usual care. RESEARCH DESIGN AND METHODS A total of 120 adult participants,with BMI 30.0-39.9 kg/m2 and HbA1c ≥8.0%,were randomized 1:1 to two treatment arms at three clinical sites in the U.S. and one in Taiwan. All patients received the lifestyle-medical management intervention for 24 months; half were randomized to also receive gastric bypass. RESULTS At 36 months, the triple end point goal was met in 9% of lifestyle-medical management patients and 28%of gastric bypass patients (P = 0.01): 10%and 19%lower than at 12 months. Mean (SD) HbA1cvalues at 3 years were 8.6% (3.5) and 6.7% (2.0) (P < 0.001). No lifestyle-medical management patient had remission of diabetes at 36 months, whereas 17% of gastric bypass patients had full remission and 19% had partial remission. Lifestyle-medicalmanagement patients usedmore medications than gastric bypass patients: Mean (SD) 3.8 (3.3) vs. 1.8 (2.4). Percent weight loss was mean (SD) 6.3% (16.1) in lifestyle-medical management vs. 21.0% (14.5) in gastric bypass (P < 0.001). Over 3 years, 24 serious or clinically significant adverse eventswere observed in lifestyle-medical management vs. 51with gastric bypass. CONCLUSIONS Gastric bypass is more effective than lifestyle-medical management intervention in achieving diabetes treatment goals, mainly by improved glycemic control. However, the effect of surgery diminishes with time and is associated with more adverse events.
Bibliographical noteFunding Information:
The DSS was supported by Covidien, Dublin, Ireland. Covidien provided funds for the clinical locations: University of Minnesota, Mayo Clinic, Columbia University, National Taiwan University Hospital, and Min-Sheng General Hospital. These studies were supported in part by National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases Nutrition and Obesity Research Center grant no. P30-DK-050456. This publication was also supported in part by National Center for Advancing Translational Sciences, National Institutes of Health, formerly the National Center for Research Resources, grants UL1 TR000040 and UL1 RR024156 to Columbia University. S.I. serves as an advisory board member for Novo Nordisk, USGI Medical, and Medica; consults for Metamodix; and receives grant support from Covidien, EnteroMedics, USGI Medical, and ReShape Medical. J.K. reports receiving institutional grant support from Covidien and receiving personal support for expert testimony and participation on the speakers bureau for Takeda. J.P.B. reports receiving institutional support for the Look AHEAD study. A.J.T. and Q.W. report receiving salary support from Covidien for the DSS, as well as supplemental salary support from the Minnesota Obesity Center. J.E.C. reports receiving institutional and personal grant support from Covidien, National Institutes of Health grant support, and travel expenses and personal support for the U.S. Food and Drug Administration Advisory Panel on Pulmonary Drugs.M.D.J. reports serving on an advisory board for Vivus and receiving institutional grant support from Aspire Bariatrics. A.V. reports receiving consulting support from Sanofi, Roche, and Novartis; institutional consulting support from Merck; and institutional grant support from Covidien, Daiichi-Sankyo, Merck, and GI Dynamics. L.A. reports receiving institutional grant support from Covidien. C.J.B. reports receiving grant support from Covidien and personal support for consultancy from EnteroMedics and Novo Nordisk. No other potential conflicts of interest relevant to this article were reported.