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Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy

Primary Purpose

Obesity

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Administration of weight loss drug (Metformin or Topiramate)
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hartford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Medication arm

No medication arm

Arm Description

Outcomes

Primary Outcome Measures

Weight loss percentage
Percent of total body weight lost

Secondary Outcome Measures

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

Full Information

First Posted
July 18, 2018
Last Updated
February 13, 2023
Sponsor
Hartford Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03603080
Brief Title
Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy
Official Title
A Prospective Randomized Study Evaluating the Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulty with enrollment and then Covid pandemic
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medication arm
Arm Type
Experimental
Arm Title
No medication arm
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Administration of weight loss drug (Metformin or Topiramate)
Intervention Description
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
Primary Outcome Measure Information:
Title
Weight loss percentage
Description
Percent of total body weight lost
Time Frame
one year
Secondary Outcome Measure Information:
Title
Rate of Diabetes Resolution
Description
Resolution of diabetes will be ascertained from the medical chart
Time Frame
One year
Title
Rate of High blood pressure resolution
Description
Resolution of high blood pressure will be ascertained from the medical chart
Time Frame
One year
Title
Rate of High cholesterol resolution
Description
Resolution of high cholesterol will be ascertained from the medical chart
Time Frame
One year
Title
Rate of GERD resolution
Description
Resolution of GERD will be ascertained from the medical chart
Time Frame
One year
Title
Rate of Sleep apnea resolution
Description
Resolution of sleep apnea will be ascertained from the medical chart
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy

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