Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01901224 · ClinicalTrials.gov registry record · Phase 4
Metformin, Muscle Energetics, and Vascular Function in Older Adults With Peripheral Artery Disease
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT01901224: Clinical Trial Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT01901224 is a Phase 4 study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 2 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01901224, a Phase 4 study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
Study Summary
The investigators are doing this research study to find out if taking Metformin improves walking ability in patients with peripheral arterial disease (PAD). In PAD the arteries (blood vessels) in the legs are narrowed because of the build up of plaque. The leg muscle can hurt in patients with PAD and this is usually described as a cramp or tiredness. This pain is called intermittent claudication. Metformin is an FDA approved medication for the treatment of diabetes. The investigators believe that Metformin may help your leg muscles work better. The investigators will enroll up to 100 subjects in order to find 60 subjects with PAD at Brigham and Women's Hospital (BWH).
Primary Outcome
PCr recovery time, measured in seconds, is a measure of skeletal muscle metabolic function. PCr is a transport molecule and reservoir of high-energy phosphate bonds, which is important for cellular energetics. Phosphocreatine regeneration depends upon the skeletal muscle mitochondrial cells capacity for oxidative phosphorylation. We will measure PCr recovery time at baseline and after 12 weeks of treatment with metformin or placebo as an in vivo measure of mitochondrial function. Higher Pcr rela
Interventions
- DRUG Placebo
- DRUG Metformin 1000 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-06 |
| Phase | Phase 4 |
Why NCT01901224 stopped before completion
NCT01901224 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01901224 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01901224 about?
NCT01901224 is a clinical study titled "Metformin, Muscle Energetics, and Vascular Function in Older Adults With Peripheral Artery Disease". The investigators are doing this research study to find out if taking Metformin improves walking ability in patients with peripheral arterial disease (PAD). In PAD the arteries (blood vessels) in the legs are narrowed because of the build up of plaque. The leg muscle can hurt in patients with PAD an...
What is the current status of trial NCT01901224?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2013-07. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01901224?
The interventions under investigation include: Placebo (DRUG), Metformin 1000 mg (DRUG).
Who is sponsoring clinical trial NCT01901224?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01901224's enrollment target sits among peer trials
2 1998th of 2000 higher than 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia