TEAM: Testosterone Supplementation and Exercise in Elderly Men

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.

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