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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: Clinical Trial Phase 4 study, sponsored by Hartford Hospital.
NCT03603080 is a Phase 4 study that was terminated before completion, run by Hartford Hospital. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percent of total body weight lost
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 |
Why NCT03603080 stopped before completion
NCT03603080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03603080's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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