NCT03603080

Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy

A Prospective Randomized Study Evaluating the Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study will investigate the effects of Metformin and Topiramate prescribed at 4 weeks post-surgery on overall weight loss at 6 months post-surgery. The investigators will study patients who, based on current diagnoses and medication regimens, could be expected to benefit the most by taking a medication to facilitate additional post-surgery weight loss. Patients scheduled to undergo laparoscopic sleeve gastrectomy (LSG) at Hartford Hospital's Bariatric and Metabolic Surgery Program will be screened, consented and enrolled in the study. Prior to surgery patients will be randomized to either pharmacotherapy or no pharmacotherapy following LSG. For those randomized to receive pharmacotherapy, medications will be initiated at 4 weeks, as this is the estimated time post-LSG at which patients advance from a liquid diet to soft foods allowing medications to be better tolerated. Once randomly assigned to the medication group, patients will receive Metformin or Topiramate based upon physician judgment and medical history. Dosages will not be adjusted during the course of the study. The primary outcome will be % total body weight loss (%TWL) at 6 months following surgery, as the majority of the weight loss after LSG occurs during the first 6 months. Data collected through up to 12 months will be analyzed. The %TWL for both arms of the study will also be assessed at 8 weeks, 16 weeks, and 9 months and one-year post-LSG. Resolution of comorbidities will be noted.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Administration of weight loss drug (Metformin or Topiramate)	Patients in this arm will receive either Metformin (500 mg, twice per day) or Topiramate (50 mg, once per day) starting at 4 weeks after laparoscopic sleeve gastrectomy

Timeline

• Start date: 2019-03-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2018-07-27
• Last updated: 2023-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study