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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Drug: Administration of weight loss drug (Metformin or Topiramate)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Medication arm	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
NO_INTERVENTION: No medication arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss percentage	Percent of total body weight lost	one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hartford Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): September 1, 2022
• Study Completion (ACTUAL): September 1, 2022

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (ACTUAL): July 27, 2018

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Hypoglycemic Agents; Physiological Effects of Drugs; Anticonvulsants; Metformin; Topiramate; Anti-Obesity Agents
• Other Study ID Numbers: HHC-2018-0155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes