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Lifestyle Intervention and Testosterone Replacement in Obese Seniors

NCT02367105 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2022-07-26

Study results available
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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.

Conditions

  • Obesity and Hypogonadism

Interventions

DRUG

Testosterone

Daily testosterone gel applied once daily in the morning to intact skin

OTHER

Lifestyle Therapy

Weekly behavioral diet to induce \~10% weight loss in combination with supervised aerobic and exercise training three times a week

DRUG

Placebo

Placebo gel for testosterone

Sponsors & Collaborators

  • Michael E. DeBakey VA Medical Center

    collaborator FED

  • Baylor College of Medicine

    collaborator OTHER

  • Biomedical Research Institute of New Mexico

    collaborator OTHER

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Dennis T Villareal, MD · Michael E. DeBakey VA Medical Center, Houston, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-01
Primary Completion
2019-07-31
Completion
2019-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02367105 on ClinicalTrials.gov