Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Drug: Administration of weight loss drug (Metformin or Topiramate)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication arm<br> | Drug: Administration of weight loss drug (Metformin or Topiramate)<br>* 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<br>|
| No Intervention: No medication arm<br> | |

What is the study measuring?
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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 |