Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy

Hartford Hospital

Status and phase

Terminated

Phase 4

Conditions

Obesity

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03603080

HHC-2018-0155

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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