Stopped: Investigator did not submit an annual continuation report with the Institutional Review Board and the study was officially removed from IRB regulatory oversight on Sep 2014, based on 32 CFR 219.109e. The study officially expired/terminated.
The investigators plan to randomize mild to moderately obese (BMI 30-34.9) subjects to medical management (diet, exercise, and best medical therapy) versus sleeve gastrectomy with medical management, with a primary endpoint of diabetes remission (normal fasting glucose, off medications and insulin) at one year. Sleeve gastrectomy (also called greater curvature gastrectomy, vertical sleeve gastrectomy, and sleeve gastroplasty) involves stapled resection of the gastric fundus. Secondary endpoints include weight loss, improvement in hypertension, sleep apnea, c-reactive protein, and fasting lipid profile.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Diabetes remission
Timeframe: 1 year