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Difficulty with enrollment and then Covid pandemic
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication arm | Experimental |
| |
| No medication arm | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of weight loss drug (Metformin or Topiramate) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss percentage | Percent of total body weight lost | one year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 13, 2023 | Dec 29, 2023 | 5 | ||
| Jun 4, 2024 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D005632 |
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| 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 |
| Jun 26, 2024 |
| 6 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 | Ketoses |