Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy

NCT03603080 | Terminated Phase 4 FDA Drug

• 1 other identifier: HHC-2018-0155
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Weight loss percentage

  Percent of total body weight lost

  one year

Secondary Outcomes (5)

• Rate of Diabetes Resolution

  One year

• Rate of High blood pressure resolution

  One year

• Rate of High cholesterol resolution

  One year

• Rate of GERD resolution

  One year

• Rate of Sleep apnea resolution

  One year

Study Arms (2)

Medication arm

EXPERIMENTAL

Drug: Administration of weight loss drug (Metformin or Topiramate)

No medication arm

NO INTERVENTION

Interventions

Administration of weight loss drug (Metformin or Topiramate) DRUG

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

Medication arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for sleeve gastrectomy as primary bariatric treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Metformin; Topiramate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: July 27, 2018
• Study Start: March 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)