Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes.
From the Departments of Internal Medicine (G.M., C.G., A.I., L.L., G.G.) and Surgery (G.N., M.C., F.R.), Università Cattolica S. Cuore; and National Research Council of Italy-Institute of Systems Analysis and Computer Science (IASI), BioMatLab (S.P., A.D.G.) – both in Rome; and the Section of Gastrointestinal Metabolic Surgery, Weill Medical College of Cornell University, New York Presbyterian Hospital, New York (A.P., F.R.).
Background Roux-en-Y gastric bypass and biliopancreatic diversion can markedly ameliorate diabetes in morbidly obese patients, often resulting in disease remission. Prospective, randomized trials comparing these procedures with medical therapy for the treatment of diabetes are needed. Methods In this single-center, nonblinded, randomized, controlled trial, 60 patients between the ages of 30 and 60 years with a body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) of 35 or more, a history of at least 5 years of diabetes, and a glycated hemoglobin level of 7.0% or more were randomly assigned to receive conventional medical therapy or undergo either gastric bypass or biliopancreatic diversion. The primary end point was the rate ofdiabetes remission at 2 years (defined as a fasting glucose level of <100 mg per deciliter [5.6 mmol per liter] and a glycated hemoglobin level of <6.5% in the absence of pharmacologic therapy). Results At 2 years, diabetes remission had occurred in no patients in the medical-therapy group versus 75% in the gastric-bypass group and 95% in the biliopancreatic-diversion group (P<0.001 for both comparisons). Age, sex, baseline BMI, duration of diabetes, and weight changes were not significant predictors ofdiabetes remission at 2 years or of improvement in glycemia at 1 and 3 months. At 2 years, the average baseline glycated hemoglobin level (8.65±1.45%) had decreased in all groups, but patients in the two surgical groups had the greatest degree of improvement (average glycated hemoglobin levels, 7.69±0.57% in the medical-therapy group, 6.35±1.42% in the gastric-bypassgroup, and 4.95±0.49% in the biliopancreatic-diversion group). Conclusions In severely obese patients with type 2 diabetes, bariatricsurgery resulted in better glucose control than did medical therapy. Preoperative BMI and weight loss did not predict the improvement in hyperglycemia after these procedures. (Funded by Catholic University of Rome; ClinicalTrials.gov number, NCT00888836 .).