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NCT03256292 · ClinicalTrials.gov registry record

Long-term Lifestyle Change and Testosterone Replacement

A clinical trial, sponsored by Baylor College of Medicine.

Completed
Registry status
38
Enrollment target

NCT03256292: Completed study, sponsored by Baylor College of Medicine.

NCT03256292 is a clinical trial that has completed, run by Baylor College of Medicine. The registered enrollment target is 38 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03256292 has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
38 participants
Enrollment target

Study Summary

Older hypogonadal obese veterans previously participated in a 6 month lifestyle change (diet-induced weight loss and exercise) study with or without testosterone replacement therapy before being followed for the following year at the clinic while receiving standard of care consisting of diet and exercise counseling (for healthy lifestyle change) and testosterone replacement therapy. This study will determine if long-term lifestyle change and testosterone replacement therapy with associated improvement in physical and metabolic health can be maintained in obese older adults.

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.

Interventions

  • DRUG Testosterone replacement
  • BEHAVIORAL lifestyle

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2017-08-21
Est. Completion 2020-08-31
Baylor College of Medicine

616 total trials

What the finished NCT03256292 record still lists

NCT03256292 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 38 participants, a relatively small participant target.

The record links to 0 conditions, and to 2 interventions - of which Testosterone replacement is the first listed.

NCT03256292 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03256292 about?

NCT03256292 is a clinical study titled "Long-term Lifestyle Change and Testosterone Replacement". Older hypogonadal obese veterans previously participated in a 6 month lifestyle change (diet-induced weight loss and exercise) study with or without testosterone replacement therapy before being followed for the following year at the clinic while receiving standard of care consisting of diet and exe...

What is the current status of trial NCT03256292?

This trial is currently completed. The enrollment target is 38 participants. The study started on 2017-08-21. Estimated completion is 2020-08-31.

What interventions are being tested in trial NCT03256292?

The interventions under investigation include: Testosterone replacement (DRUG), lifestyle (BEHAVIORAL).

Who is sponsoring clinical trial NCT03256292?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03256292, the US trial registry maintained by the National Library of Medicine. NCT03256292 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.