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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 114 participants
Start Date 2021-05-14
Est. Completion 2025-07-31
Phase Phase 3

Sponsor

VA Office of Research and Development

1,668 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.