At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Testosterone Replacement to Augment Lifestyle Therapy in Obese Older Veterans
In Brief
A Phase 3 clinical trial evaluating Testosterone, Lifestyle Therapy, and 1 other intervention for Obesity and Hypogonadism. Completed, enrolled 83 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Daily testosterone gel applied once daily in the morning to intact skin
Weekly behavioral diet to induce \~10% weight loss in combination with supervised aerobic and exercise training three times a week
Placebo gel for testosterone