TY - JOUR
T1 - 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
T2 - A randomized control trial
AU - Ikramuddin, Sayeed
AU - Korner, Judith
AU - Lee, Wei Jei
AU - Bantle, John P.
AU - Thomas, Avis J.
AU - Connett, John E.
AU - Leslie, Daniel B.
AU - Inabnet, William B.
AU - Wang, Qi
AU - Jeffery, Robert W.
AU - Chong, Keong
AU - Chuang, Lee Ming
AU - Jensen, Michael D.
AU - Vella, Adrian
AU - Ahmed, Leaque
AU - Belani, Kumar
AU - Olofson, Amy E.
AU - Bainbridge, Heather A.
AU - Billington, Charles J.
N1 - Publisher Copyright:
© 2016 by the American Diabetes Association.
PY - 2016/9/1
Y1 - 2016/9/1
N2 - 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.
AB - 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.
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U2 - 10.2337/dc15-2481
DO - 10.2337/dc15-2481
M3 - Article
C2 - 27311493
AN - SCOPUS:84986238385
SN - 0149-5992
VL - 39
SP - 1510
EP - 1518
JO - Diabetes Care
JF - Diabetes Care
IS - 9
ER -