Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy

Phase 4

Terminated

• Conditions: Obesity
• Interventions: Drug: Administration of weight loss drug (Metformin or Topiramate)

• Registration Number: NCT03603080
• Lead Sponsor: Hartford Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-27
• Study Start: 2019-03-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patients scheduled for sleeve gastrectomy as primary bariatric treatment

Exclusion Criteria

• Qualified for Roux en Y gastric bypass
• On FDA approved weight loss medications prior to bariatric surgery
• Required to continue Topiramate, Zonisamide, and Buproprion for other chronic diseases after bariatric surgery
• On Metformin, Dulaglutide, Exenatide, Exenatide Extended Release, Liraglutide, Empaglifozin, Canaglifozin, Dapaglifozin, Buproprion, Zonisamide, and Topiramate, prior to surgery.
• Have had lap band or other prior bariatric surgery
• Glomular filtration rate < 45
• Over 70 years old
• Not fluent in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medication arm	Administration of weight loss drug (Metformin or Topiramate)	-

Primary Outcome Measures

Name	Time	Method
Weight loss percentage	one year	Percent of total body weight lost

Secondary Outcome Measures

Name	Time	Method
Rate of High cholesterol resolution	One year	Resolution of high cholesterol will be ascertained from the medical chart
Rate of GERD resolution	One year	Resolution of GERD will be ascertained from the medical chart
Rate of Sleep apnea resolution	One year	Resolution of sleep apnea will be ascertained from the medical chart
Rate of Diabetes Resolution	One year	Resolution of diabetes will be ascertained from the medical chart
Rate of High blood pressure resolution	One year	Resolution of high blood pressure will be ascertained from the medical chart

Trial Locations

Locations (1)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States