1. 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.
- Author
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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., and Lee, Wei-Jei
- Subjects
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 - Abstract
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/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.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) 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.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. [ABSTRACT FROM AUTHOR]- Published
- 2016
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