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NCT03603080 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy
A Phase 4 study, sponsored by Hartford Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT03603080 is a Phase 4 study that was terminated before completion, run by Hartford Hospital. The registered enrollment target is 12 participants.
The verdict
NCT03603080, a Phase 4 study, was terminated before completion, sponsored by Hartford Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study 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.
Interventions
- DRUG Administration of weight loss drug (Metformin or Topiramate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2022-09-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03603080
The ClinicalTrials.gov registry entry for NCT03603080 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hartford Hospital, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Administration of weight loss drug (Metformin or Topiramate) is the first listed.
NCT03603080 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03603080 about?
NCT03603080 is a clinical study titled "Efficacy of Pharmacotherapy to Enhance Weight Loss Following Sleeve Gastrectomy". 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 medi...
What is the current status of trial NCT03603080?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2019-03-01. Estimated completion is 2022-09-01.
What interventions are being tested in trial NCT03603080?
The interventions under investigation include: Administration of weight loss drug (Metformin or Topiramate) (DRUG).
Who is sponsoring clinical trial NCT03603080?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
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