Trials / Completed
CompletedNCT03256292
Long-term Lifestyle Change and Testosterone Replacement
Long-term Lifestyle Change in Obese Older Veterans
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 38 (actual)
- Sponsor
- Baylor College of Medicine · Academic / Other
- Sex
- Male
- Age
- 65 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Background: There are studies on long-term testosterone replacement in older adults with hypogonadism showing benefits on body composition, sexual function and mood but not on testosterone replacement therapy in combination with lifestyle change (diet-induced weight loss and exercise) in the specific population of older adults with both obesity and hypogonadism. Purpose: To 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 . Design: Overweight/obese older veteran patients with obesity and hypogonadism who are being followed at the endocrine clinic while receiving standard of care consisting of diet and exercise counseling (for healthy lifestyle change) and testosterone replacement therapy will be recruited for testing of physical, metabolic, cognitive/mood, quality of life, and body composition testing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Testosterone replacement | Testosterone replacement therapy |
| BEHAVIORAL | lifestyle | lifestyle intervention consisting of diet and increased physical activity |
Timeline
- Start date
- 2017-08-21
- Primary completion
- 2020-08-31
- Completion
- 2020-08-31
- First posted
- 2017-08-22
- Last updated
- 2021-03-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03256292. Inclusion in this directory is not an endorsement.