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

• Published in: Diabetes care Vol. 39; no. 9; pp. 1510 - 1518
• Main Authors: Ikramuddin, Sayeed, Korner, Judith, Lee, Wei-Jei, Bantle, John P, Thomas, Avis J, Connett, John E, Leslie, Daniel B, Inabnet, 3rd, William B, Wang, Qi, Jeffery, Robert W, Chong, Keong, Chuang, Lee-Ming, Jensen, Michael D, Vella, Adrian, Ahmed, Leaque, Belani, Kumar, Olofson, Amy E, Bainbridge, Heather A, Billington, Charles J
• Format: Journal Article
• Language: English
• Published: United States American Diabetes Association 01-09-2016
• Subjects: Adult; Blood Glucose - analysis; Blood Pressure; Cholesterol, LDL - blood; Clinical Care/Education/Nutrition/Psychosocial Research; Clinical outcomes; Combined Modality Therapy; Diabetes; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - etiology; Diabetes Mellitus, Type 2 - therapy; Female; Gastric Bypass - methods; Gastrointestinal surgery; Glycated Hemoglobin A - analysis; Goals; Humans; Hypoglycemic Agents - administration & dosage; Life Style; Lifestyles; Low density lipoprotein; Male; Middle Aged; Obesity - blood; Obesity - complications; Obesity - therapy; Remission Induction - methods; Risk Reduction Behavior; Taiwan; Time Factors; Treatment Outcome; United States; Weight control; Weight Loss - physiology; United States > US; Taiwan
• ISSN: 0149-5992; 1935-5548
• DOI: 10.2337/dc15-2481

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.
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.
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.
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.