Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: The diabetes surgery study randomized clinical trial
Journal
JAMA - Journal of the American Medical Association
Journal Volume
309
Journal Issue
21
Pages
2240-2249
Date Issued
2013
Author(s)
Ikramuddin S.
Korner J.
Lee W.-J.
Connett J.E.
Inabnet III W.B.
Billington C.J.
Thomas A.J.
Leslie D.B.
Chong K.
Jeffery R.W.
Ahmed L.
Vella A.
Bessler M.
Sarr M.G.
Swain J.M.
Laqua P.
Jensen M.D.
Bantle J.P.
Abstract
Importance: Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown. Objective: To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors. Design, Setting, and Participants: A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008. Interventions: Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized. Main Outcomes and Measures: Composite goal of HbA 1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg. Results: All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group. Conclusions and Relevance: In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events. Trial Registration: clinicaltrials.gov Identifier: NCT00641251. ?2013 American Medical Association. All rights reserved.
SDGs
Other Subjects
C peptide; hemoglobin A1c; low density lipoprotein cholesterol; adult; adverse outcome; article; body mass; cardiovascular disease; clinical effectiveness; comorbidity; comparative effectiveness; controlled study; disease control; female; human; hyperlipidemia; hypertension; hypoglycemia; intermethod comparison; lifestyle modification; major clinical study; male; non insulin dependent diabetes mellitus; nutritional deficiency; peroperative complication; postoperative complication; priority journal; randomized controlled trial; risk factor; Roux Y anastomosis; stomach bypass; systolic blood pressure; Taiwan; teaching hospital; United States; weight reduction
Type
journal article