Sayeed Ikramuddin1, Judith Korner2, Wei-Jei Lee3, John P Bantle4, Avis J Thomas5, John E Connett5, Daniel B Leslie6, William B Inabnet7, Qi Wang5, Robert W Jeffery8, Keong Chong9, Lee-Ming Chuang10, Michael D Jensen11, Adrian Vella11, Leaque Ahmed12, Kumar Belani13, Amy E Olofson11, Heather A Bainbridge2, Charles J Billington4. 1. Department of Surgery, University of Minnesota, Minneapolis, MN ikram001@umn.edu. 2. Division of Endocrinology, Department of Medicine, Columbia University Medical Center, New York, NY. 3. Surgery Department, National Taiwan University Hospital, Taipei City, Taiwan. 4. Department of Medicine, Division of Endocrinology and Diabetes, University of Minnesota, Minneapolis, MN. 5. Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN. 6. Department of Surgery, University of Minnesota, Minneapolis, MN. 7. Division of Metabolic, Endocrine, and Minimally Invasive Surgery, Mount Sinai Medical Center, New York, NY. 8. Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN. 9. Department of Endocrinology, Min-Sheng General Hospital, Taoyuan City, Taiwan. 10. Division of Metabolism and Endocrinology, Internal Medicine Department, National Taiwan University Hospital, Taipei City, Taiwan. 11. Division of Endocrinology and Diabetes, Department of Medicine, Mayo Clinic, Rochester, MN. 12. Department of Surgery, Harlem Hospital Center, New York, NY. 13. Department of Anesthesiology, University of Minnesota, Minneapolis, MN.
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.
RCT Entities:
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.
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