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NCT04221750 · ClinicalTrials.gov registry record · Phase 3
Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors
A Phase 3 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 114
- Enrollment target
NCT04221750: Completed Phase 3 study, sponsored by VA Office of Research and Development.
NCT04221750 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 114 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04221750, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 114 participants
- Enrollment target
Study Summary
The continuing increase in prevalence of obesity in older adults including many older Veterans has become a major health concern. The clinical trial will test the central hypothesis that a multicomponent intervention consisting of lifestyle therapy (diet-induced weight loss and exercise training) plus metformin will be the most effective strategy for reversing sarcopenic obesity and frailty in older Veterans with obesity.
Interventions
- DRUG Placebo
- DRUG Metformin Hydrochloride
- BEHAVIORAL Lifestyle therapy
- BEHAVIORAL Healthy Lifestyle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2021-05-14 |
| Est. Completion | 2025-07-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04221750
The ClinicalTrials.gov registry entry for NCT04221750 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04221750 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04221750 about?
NCT04221750 is a clinical study titled "Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors". The continuing increase in prevalence of obesity in older adults including many older Veterans has become a major health concern. The clinical trial will test the central hypothesis that a multicomponent intervention consisting of lifestyle therapy (diet-induced weight loss and exercise training) pl...
What is the current status of trial NCT04221750?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 114 participants. The study started on 2021-05-14. Estimated completion is 2025-07-31.
What interventions are being tested in trial NCT04221750?
The interventions under investigation include: Placebo (DRUG), Metformin Hydrochloride (DRUG), Lifestyle therapy (BEHAVIORAL), Healthy Lifestyle (BEHAVIORAL).
Who is sponsoring clinical trial NCT04221750?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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