Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Weight loss percentage [one year]
Percent of total body weight lost
Secondary Outcome Measures
- Rate of Diabetes Resolution [One year]
Resolution of diabetes will be ascertained from the medical chart
- Rate of High blood pressure resolution [One year]
Resolution of high blood pressure will be ascertained from the medical chart
- Rate of High cholesterol resolution [One year]
Resolution of high cholesterol will be ascertained from the medical chart
- Rate of GERD resolution [One year]
Resolution of GERD will be ascertained from the medical chart
- Rate of Sleep apnea resolution [One year]
Resolution of sleep apnea will be ascertained from the medical chart
Eligibility Criteria
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.
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Have had lap band or other prior bariatric surgery
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Glomular filtration rate < 45
-
Over 70 years old
-
Not fluent in English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hartford Hospital | Hartford | Connecticut | United States | 06102 |
Sponsors and Collaborators
- Hartford Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HHC-2018-0155