Long-term Lifestyle Change and Testosterone Replacement (LITE)

Baylor College of Medicine

Status: Completed

Conditions: Aging; Overweight and Obesity; Hypogonadism

Treatments: Drug: Testosterone replacement; Behavioral: lifestyle

Study type: Observational

Funder types: Other

Identifiers

NCT03256292

H-40598

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: Male

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Overweight/obese (BMI = or > 27 kg/m2)
• Older (65-85 yr)
• Male veteran patients being seen at the PI's endocrine clinic and receiving standard of care consisting of diet and regular exercise counseling
• Diagnosed with hypogonadism on current or previous testosterone replacement at the PI's endocrine clinic
• Willing to provide informed consent

Exclusion criteria

• Failure to provide informed consent
• Unstable cardiopulmonary disease (e.g. recent MI, unstable angina, stroke) or unstable disease (Class III or IV congestive heart failure).

Trial design

38 participants in 1 patient group

testosterone, diet, and increased physical activity

Description:

Group receiving standard of care consisting of diet and regular exercise counseling + testosterone replacement therapy

Treatment:

Behavioral: lifestyle

Drug: Testosterone replacement