Clinical trial NCT00112151: TEAM: Testosterone Supplementation and Exercise in Elderly Men
Official title: Testosterone Supplementation and Exercise in Elderly Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: andropause
hypogonadism
AndroGel
exercise
PRT
Testosterone
T supplementation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2005-05-30
Enrollment: 167
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of testosterone supplementation (AndroGel) on body composition, strength, endurance, cognition, and function in older men.

Detailed description: Studies suggest that testosterone (T) replacement in healthy elderly men has beneficial effects on body composition, muscle, bone, memory, and behavior, but the risks of chronic treatment, especially on the prostate, heart, and sleep quality, are not entirely clear. Therefore, it is most desirable to supplement into the lowest "effective" range in elderly men. However, the effects of lower than usual replacement T doses have not been well studied. Furthermore, the possible important interaction of exercise to enhance the positive effects of T supplementation, yet mitigate the possible side effects, has not been studied in older men.

This one-year study will enroll 150 men with low-normal to slightly below normal serum total T levels. Participants will be randomized into one of 6 treatment groups to receive T supplementation (AndroGel) of 25mg/day, 50 mg/day or a placebo crossed with progressive resistance training (PRT) exercise 3 times a week versus none. At the end of the study, participants in the exercise-control group will be offered PRT.

Please see link below for updated version of full protocol.

Eligibility criteria: Inclusion Criteria:

* Generally healthy, untrained men 60 years or older with low-normal testosterone levels (200-350ng/dL)
* Must reside in the Denver metro area

Exclusion Criteria:

* Prostate/breast cancer
* Unable to exercise safely
* severe obesity (\>34 body mass index \[BMI\])
* Polycythemia
* Diabetes
* Use of drugs that could affect T levels
* Cognitive dysfunction (MMSE less than 24)
* PSA above the age-adjusted normal level or AUA greater than 19
* Unable to pass stress test due to active CAD

Primary outcomes:
measure: Physical Function (CS-PFP Total Score)
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Upper Body Muscle Strength (1-RM, kg)
timeFrame: Baseline and 12 months
measure: Lower Body Muscle Strength (1-RM, kg)
timeFrame: Baseline and 12 months
measure: Power (Power Rig, Watts)
timeFrame: Baseline and 12 months
measure: Fat Mass (kg)
timeFrame: Baseline and 12 months
measure: Fat Free Mass (kg)
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Robert S. Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Myers BL, Badia P. Changes in circadian rhythms and sleep quality with aging: mechanisms and interventions. Neurosci Biobehav Rev. 1995 Winter;19(4):553-71. doi: 10.1016/0149-7634(95)00018-6.