Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03603080
• Other study ID #: HHC-2018-0155
• Status: Terminated
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2023
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss percentage	Percent of total body weight lost	one year
Secondary	Rate of Diabetes Resolution	Resolution of diabetes will be ascertained from the medical chart	One year
Secondary	Rate of High blood pressure resolution	Resolution of high blood pressure will be ascertained from the medical chart	One year
Secondary	Rate of High cholesterol resolution	Resolution of high cholesterol will be ascertained from the medical chart	One year
Secondary	Rate of GERD resolution	Resolution of GERD will be ascertained from the medical chart	One year
Secondary	Rate of Sleep apnea resolution	Resolution of sleep apnea will be ascertained from the medical chart	One year