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Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy

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ClinicalTrials.gov Identifier: NCT03603080
Recruitment Status : Suspended (Difficulty with enrollment and then Covid pandemic)
First Posted : July 27, 2018
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Administration of weight loss drug (Metformin or Topiramate) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study Evaluating the Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Weight loss percentage [ Time Frame: one year ]
    Percent of total body weight lost


Secondary Outcome Measures :
  1. Rate of Diabetes Resolution [ Time Frame: One year ]
    Resolution of diabetes will be ascertained from the medical chart

  2. Rate of High blood pressure resolution [ Time Frame: One year ]
    Resolution of high blood pressure will be ascertained from the medical chart

  3. Rate of High cholesterol resolution [ Time Frame: One year ]
    Resolution of high cholesterol will be ascertained from the medical chart

  4. Rate of GERD resolution [ Time Frame: One year ]
    Resolution of GERD will be ascertained from the medical chart

  5. Rate of Sleep apnea resolution [ Time Frame: One year ]
    Resolution of sleep apnea will be ascertained from the medical chart



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603080


Locations
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United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
Hartford Hospital
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Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT03603080    
Other Study ID Numbers: HHC-2018-0155
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Metformin
Topiramate
Anti-Obesity Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Anticonvulsants