Clinical trial NCT03603080: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Obesity
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight loss percentage
timeFrame: one year
Secondary outcomes:
measure: Rate of Diabetes Resolution
timeFrame: One year
measure: Rate of High blood pressure resolution
timeFrame: One year
measure: Rate of High cholesterol resolution
timeFrame: One year
measure: Rate of GERD resolution
timeFrame: One year
measure: Rate of Sleep apnea resolution
timeFrame: One year
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
References: