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NCT01804049 · ClinicalTrials.gov registry record · Phase 1
Metformin and Muscle in Insulin-resistant Older Veterans
A Phase 1 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT01804049: Completed Phase 1 study, sponsored by VA Office of Research and Development.
NCT01804049 is a Phase 1 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01804049, a Phase 1 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
Sarcopenia is the loss of muscle mass, strength and function with aging and is associated with increased disability, falls and fractures. Older adults with diabetes and prediabetes are insulin resistant and have a higher risk of developing sarcopenia. This study examines the use of metformin, an antidiabetic drug, for preventing the development of sarcopenia in older adults with prediabetes.
Primary Outcome
At baseline, 1, 2, and 3 year follow-up visits, participants will have whole body dual x-ray absorptiometry scans (DXA) with a Hologic QDR 4500W DXA scanner by a certified DXA operator to determine total body lean mass and appendicular lean mass (Kg). The changes in appendicular and total lean mass were calculated by determining the change from baseline to the three year data point. If participants withdrew from the study prior to collection of 3 year data, the final time point available was use
Interventions
- DRUG placebo
- DRUG metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2014-04-08 |
| Est. Completion | 2018-08-31 |
| Phase | Phase 1 |
What the finished NCT01804049 record still lists
NCT01804049 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01804049 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01804049 about?
NCT01804049 is a clinical study titled "Metformin and Muscle in Insulin-resistant Older Veterans". Sarcopenia is the loss of muscle mass, strength and function with aging and is associated with increased disability, falls and fractures. Older adults with diabetes and prediabetes are insulin resistant and have a higher risk of developing sarcopenia. This study examines the use of metformin, an ant...
What is the current status of trial NCT01804049?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2014-04-08. Estimated completion is 2018-08-31.
What interventions are being tested in trial NCT01804049?
The interventions under investigation include: placebo (DRUG), metformin (DRUG).
Who is sponsoring clinical trial NCT01804049?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01804049's enrollment target sits among peer trials
120 479th of 2000 higher than 1,503 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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