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.

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.

• Authors: Sayeed Ikramuddin, Judith Korner, Wei-Jei Lee, John P Bantle, Avis J Thomas, John E Connett, Daniel B Leslie, William B Inabnet 3rd, Qi Wang, Robert W Jeffery, Keong Chong, Lee-Ming Chuang, Michael D Jensen, Adrian Vella, Leaque Ahmed, Kumar Belani, Amy E Olofson, Heather A Bainbridge, Charles J Billington
• Journal: Diabetes care (Diabetes Care) Vol. 39 Issue 9 Pg. 1510-8 (Sep 2016) ISSN: 1935-5548 [Electronic] United States
• PMID: 27311493 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2016 by the American Diabetes Association.

Chemical References

• Blood Glucose
• Cholesterol, LDL
• Glycated Hemoglobin A
• Hypoglycemic Agents
• hemoglobin A1c protein, human

Topics

• Adult
• Blood Glucose (analysis)
• Blood Pressure
• Cholesterol, LDL (blood)
• Combined Modality Therapy
• Diabetes Mellitus, Type 2 (blood, etiology, therapy)
• Female
• Gastric Bypass (methods)
• Glycated Hemoglobin (analysis)
• Goals
• Humans
• Hypoglycemic Agents (administration & dosage)
• Life Style
• Male
• Middle Aged
• Obesity (blood, complications, therapy)
• Remission Induction (methods)
• Risk Reduction Behavior
• Taiwan
• Time Factors
• Treatment Outcome
• United States
• Weight Loss (physiology)