100
Participants
Start Date
August 1, 2025
Primary Completion Date
December 31, 2028
Study Completion Date
March 31, 2029
Roux-en-Y Gastric Bypass or Sleeve Gastrectomy
Patients receive either RYGB or SG. The surgical risk, differential impact of each procedure on body weight and other obesity-related diseases, presence of other medical and mental problems, patient's behavioral factors (e.g., postoperative compliance, active smoking), medications, and goals will be considered when the patient and local medical team make a shared decision about the most appropriate surgical procedure.
Anti-Obesity Medication (AOM) treatment
Implementation of obesity pharmacotherapy in the nonsurgical group includes initial assessment of side effects and response, followed by achieving a clinically meaningful weight loss (5% weight loss) after three months. Once this goal is reached, AOMs will be continued throughout the study. If a weight plateau is reached within the first AOM, then another AOM may be added in combination in a stepwise fashion. The choice of AOMs considered may include metformin, topiramate, liraglutide, dulaglutide, semaglutide, tirzepatide, and empagliflozin.
The Cleveland Clinic, Cleveland
Ethicon, Inc.
INDUSTRY
iRhythm Technologies, Inc.
INDUSTRY
Ali Aminian
OTHER