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.
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.
Department of Surgery, University of Minnesota, Minneapolis, MN ikram001@umn.edu.
Sayeed
S
Ikramuddin
Division of Endocrinology, Department of Medicine, Columbia University Medical Center, New York, NY.
Judith
J
Korner
Surgery Department, National Taiwan University Hospital, Taipei City, Taiwan.
Wei-Jei
WJ
Lee
Department of Medicine, Division of Endocrinology and Diabetes, University of Minnesota, Minneapolis, MN.
John P
JP
Bantle
Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.
Avis J
AJ
Thomas
Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.
John E
JE
Connett
Department of Surgery, University of Minnesota, Minneapolis, MN.
Daniel B
DB
Leslie
Division of Metabolic, Endocrine, and Minimally Invasive Surgery, Mount Sinai Medical Center, New York, NY.
William B
WB
Inabnet
Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.
Qi
Q
Wang
Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN.
Robert W
RW
Jeffery
Department of Endocrinology, Min-Sheng General Hospital, Taoyuan City, Taiwan.
Keong
K
Chong
Division of Metabolism and Endocrinology, Internal Medicine Department, National Taiwan University Hospital, Taipei City, Taiwan.
Lee-Ming
LM
Chuang
Division of Endocrinology and Diabetes, Department of Medicine, Mayo Clinic, Rochester, MN.
Michael D
MD
Jensen
Division of Endocrinology and Diabetes, Department of Medicine, Mayo Clinic, Rochester, MN.
Adrian
A
Vella
Department of Surgery, Harlem Hospital Center, New York, NY.
Leaque
L
Ahmed
Department of Anesthesiology, University of Minnesota, Minneapolis, MN.
Kumar
K
Belani
Division of Endocrinology and Diabetes, Department of Medicine, Mayo Clinic, Rochester, MN.
Amy E
AE
Olofson
Division of Endocrinology, Department of Medicine, Columbia University Medical Center, New York, NY.
Heather A
HA
Bainbridge
Department of Medicine, Division of Endocrinology and Diabetes, University of Minnesota, Minneapolis, MN.
Charles J
CJ
Billington
D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure; D008078:Cholesterol, LDL / Q000097:blood; D003131:Combined Modality Therapy; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000209:etiology / Q000628:therapy*; D005260:Female; D015390:Gastric Bypass / Q000379:methods*; D006442:Glycated Hemoglobin / Q000032:analysis; D006040:Goals; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000097:blood / Q000150:complications / Q000628:therapy*; D012074:Remission Induction / Q000379:methods; D040242:Risk Reduction Behavior; D013624:Taiwan; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D015431:Weight Loss / Q000502:physiology
D001786:Blood Glucose; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; C517652:hemoglobin A1c protein, human