Long-term Lifestyle Change and Testosterone Replacement
- Conditions
- Overweight and ObesityHypogonadismAging
- Interventions
- Behavioral: lifestyle
- Registration Number
- NCT03256292
- Lead Sponsor
- Baylor College of Medicine
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 38
- 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
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description testosterone, diet, and increased physical activity lifestyle Group receiving standard of care consisting of diet and regular exercise counseling + testosterone replacement therapy testosterone, diet, and increased physical activity Testosterone replacement Group receiving standard of care consisting of diet and regular exercise counseling + testosterone replacement therapy
- Primary Outcome Measures
Name Time Method Change in body weight 18 month Measured after an overnight fast using calibrated scales
Change in Physical Performance Test score 18 month 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.
- Secondary Outcome Measures
Name Time Method Sexual function 18 month Using the International Index of Erectile Function
Change in balance 18 month as measured by leg stance and obstacle course
Change in gait 18 month as measured by completing the time to walk a certain distance
Change in Stroop color naming 18 month using cognitive instrument testing
Change in lipid profile 18 months measured in the blood
Cortical to total area 18 months assessed by pQCT
Change in vitamin D level 18 months measured in the blood
Change in prostate specific antigen 18 month measured in the blood
Mood 18 month Using the Geriatric Depression Scale
Change in Modified mini-mental exam 18 month using cognitive instrument testing
Change in testosterone level 18 month as measured in the blood
Change in Composite cognitive z-score 18 month using cognitive instrument testing
Change in waist circumference 18 month as measured
Change in blood pressure 18 month as measured by sphygmomanometry
Volumetric BMD 18 month Assessed by using peripheral quantitative computed tomography (pQCT)
Biochemical Markers of Bone Turnover (Serum C-terminal telopeptide (CTX) 18 month measured by ELISA
Change in sex hormone globulin 18 month as measured in the blood
Change in metabolic hormones 18 month Leptin, adiponectin, and similar metabolic hormones as measured in the blood
Change in Ray auditory verbal learning test 18 month using cognitive instrument testing
Change in Trail A/B 18 month using cognitive instrument testing
Change in metabolic syndrome 18 month using harmonized metabolic syndrome criteria
bone strength index 18 months assessed by pQCT
Change in density weighted polar section modulus 18 months assessed by pQCT
Change in cortical density 18 months assessed by pQCT
Change in cortical area 18 months assessed by pQCT
Change in body composition (lean mass, fat mass and bone mineral density) 18 month Assessed by using dual-energy x-ray absorptiometry
Prostate Symptom Assessment 18 month Using the International Prostate Symptom Scoring
Quality of Life 18 month Using SF-36 and impact of weight on quality of life short form (IWQOL-lite)
Change in muscle strength and quality 18 month Using biodex dynamometry
Change in Functional Status 18 month Using functional status questionnaire
Change in bone quality 18 month Using HrpQCT
Change in serum PTH 18 month as measured in the blood
Change in trabecular bone score 18 month Using DXA
Change in Word list fluency 18 month using cognitive instrument testing
Change in Biochemical Markers of Bone Turnover (PINP) 18 months measured by RIA
Trial Locations
- Locations (1)
Michael E DeBakey VA Medical Center
🇺🇸Houston, Texas, United States