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- Title
Durability of Addition of Roux-en-Y Gastric Bypass to Lifestyle Intervention and Medical Management in Achieving Primary Treatment Goals for Uncontrolled Type 2 Diabetes in Mild to Moderate Obesity: A Randomized Control Trial.
- Authors
Ikramuddin, Sayeed; Korner, Judith; Wei-Jei Lee; Bantle, John P.; Thomas, Avis J.; Connett, John E.; Leslie, Daniel B.; Inabnet III, William B.; Qi Wang; Jeffery, Robert W.; Keong Chong; Lee-Ming Chuang; Jensen, Michael D.; Vella, Adrian; Ahmed, Leaque; Belani, Kumar; Olofson, Amy E.; Bainbridge, Heather A.; Billington, Charles J.; Lee, Wei-Jei
- Abstract
<bold>Objective: </bold>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.<bold>Research Design and Methods: </bold>A total of 120 adult participants, with BMI 30.0-39.9 kg/m(2) 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.<bold>Results: </bold>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) HbA1c values 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-medical management patients used more 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 events were observed in lifestyle-medical management vs. 51 with gastric bypass.<bold>Conclusions: </bold>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.
- Subjects
TAIWAN; UNITED States; LOW density lipoprotein receptors; GASTRIC bypass; BARIATRIC surgery; DIABETES; GLYCEMIC control; BLOOD sugar analysis; TYPE 2 diabetes treatment; OBESITY treatment; OBESITY complications; BEHAVIOR; BLOOD pressure; COMBINED modality therapy; COMPARATIVE studies; GLYCOSYLATED hemoglobin; GOAL (Psychology); HYPOGLYCEMIC agents; LOW density lipoproteins; RESEARCH methodology; MEDICAL cooperation; TYPE 2 diabetes; OBESITY; RESEARCH; RESEARCH funding; TIME; WEIGHT loss; EVALUATION research; LIFESTYLES; RANDOMIZED controlled trials; TREATMENT effectiveness; DISEASE remission
- Publication
Diabetes Care, 2016, Vol 39, Issue 9, p1510
- ISSN
0149-5992
- Publication type
journal article
- DOI
10.2337/dc15-2481