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NCT02367105 · ClinicalTrials.gov registry record · Phase 3
Lifestyle Intervention and Testosterone Replacement in Obese Seniors
A Phase 3 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 83
- Enrollment target
NCT02367105: Completed Phase 3 study, sponsored by VA Office of Research and Development.
NCT02367105 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 83 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02367105, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 83 participants
- Enrollment target
Study Summary
The prevalence of obesity in Veterans is greater than in the general population, and even more so among users of the VA Health Care System. In addition, the population of obese older Veterans is rapidly increasing as more baby boomers become senior citizens. In older Veterans, obesity exacerbates the age- related decline in physical function and causes frailty which predisposes to admission to a VA chronic care facility. However, the optimal clinical approach to obesity in older adults is controversial because of the concern that weight loss therapy could be harmful by aggravating the age-related loss of muscle mass and bone mass. In fact, the MOVE (Managing Overweight/Obese Veterans) program does not have any guidelines for eligible Veterans if they are 70 or older. It is possible that the addition of testosterone replacement to lifestyle therapy will preserve muscle mass and bone mass and reverse frailty in obese older Veterans and thus prevent their loss of independence and decrease demand for VA health care services.
Primary Outcome
The primary functional outcome is the modified physical performance test, which includes seven standardized tasks (walking 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 tests) plus two additional tasks (climbing up and down four flights of stairs and performing a 360-degree turn). The score for each task ranges form 0 to 4; a perfect score is 36. Higher scores indicate bette
Interventions
- DRUG Placebo
- DRUG Testosterone
- OTHER Lifestyle Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2015-02-01 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 3 |
What the finished NCT02367105 record still lists
NCT02367105 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02367105 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02367105 about?
NCT02367105 is a clinical study titled "Lifestyle Intervention and Testosterone Replacement in Obese Seniors". The prevalence of obesity in Veterans is greater than in the general population, and even more so among users of the VA Health Care System. In addition, the population of obese older Veterans is rapidly increasing as more baby boomers become senior citizens. In older Veterans, obesity exacerbates th...
What is the current status of trial NCT02367105?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 83 participants. The study started on 2015-02-01. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT02367105?
The interventions under investigation include: Placebo (DRUG), Testosterone (DRUG), Lifestyle Therapy (OTHER).
Who is sponsoring clinical trial NCT02367105?
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 NCT02367105's enrollment target sits among peer trials
83 1751st of 2000 higher than 249 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
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