This is a randomized controlled trial employing a Sequential Multiple Assignment Randomized Trial (SMART) design to test whether pharmacotherapy, in conjunction with lifestyle counseling, can reverse weight regain after bariatric surgery.
Male and female subjects aged 18-70 years
Had sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) at least 18 months ago
Weight regain of ≥5% relative to post-surgery nadir weight
Body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with weight-related comorbidities
Type 1 diabetes
Insulin-dependent type 2 diabetes
Fasting plasma glucose (FPG) ≥240 mg/dL
Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥100 mm Hg on the average of three seated measurements after being at rest for at least 5 minutes
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Treatment groupsSee each treatment group below.
University of California, Irvine
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator