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

Sayeed Ikramuddin, Judith Korner, Wei Jei Lee, John P. Bantle, Avis J. Thomas, John E. Connett, Daniel B. Leslie, William B. Inabnet, Qi Wang, Robert W. Jeffery, Keong Chong, Lee Ming Chuang, Michael Dennis Jensen, Adrian Vella, Leaque Ahmed, Kumar Belani, Amy E. Olofson, Heather A. Bainbridge, Charles J. Billington

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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/m2 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) HbA1cvalues 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-medicalmanagement patients usedmore 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 eventswere observed in lifestyle-medical management vs. 51with 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.

Original languageEnglish (US)
Pages (from-to)1510-1518
Number of pages9
JournalDiabetes Care
Volume39
Issue number9
DOIs
StatePublished - Sep 1 2016

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ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Medicine(all)
  • Advanced and Specialized Nursing

Cite this

Ikramuddin, S., Korner, J., Lee, W. J., Bantle, J. P., Thomas, A. J., Connett, J. E., Leslie, D. B., Inabnet, W. B., Wang, Q., Jeffery, R. W., Chong, K., Chuang, L. M., Jensen, M. D., Vella, A., Ahmed, L., Belani, K., Olofson, A. E., Bainbridge, H. A., & Billington, C. J. (2016). 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. Diabetes Care, 39(9), 1510-1518. https://doi.org/10.2337/dc15-2481