Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). 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.
Primary Outcome
The Physical Performance Test includes seven standardized tasks (walking 15.2 m \[50 ft\], putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg test) plus two additional tasks (going up and down four flights of stairs and making a 360-degree turn). The score for each task ranges from 0 to 4, with higher scores indicating better physical performance; a perfect score would be 36.
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 |
What the finished NCT04221750 record still lists
NCT04221750 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04221750 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04221750's enrollment target sits among peer trials
114 1648th of 2000 higher than 350 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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 enrollment target
- NCT04522791 · 114 participants · Phase 2
Breathing, Relaxation, Attention Training, & Health in Older Adults (BREATHE)
- NCT04875052 · 114 participants · NA
Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury
- NCT05100342 · 114 participants
Prospective Validation of a Points Score System Predicting 30-day Survival
- NCT05224089 · 114 participants · Phase 4
Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI