TEAM: Testosterone Supplementation and Exercise in Elderly Men

University of Colorado Denver (CU Denver)

Status and phase

Completed

Phase 2

Conditions

Healthy

Treatments

Drug: Placebo

Drug: LowT

Drug: HighT

Behavioral: Resistance Training

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00112151

R01AG019339 (U.S. NIH Grant/Contract)

02-1056

Details and patient eligibility

About

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.

Full 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.

Enrollment

167 patients

Sex

Male

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

167 participants in 6 patient groups, including a placebo group

LowT+Resistance Training

Experimental group

Description:

Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml) 1 year standard Progressive Resistance Training(PRT) program

Treatment:

Behavioral: Resistance Training

Drug: LowT

LowT+No Resistance training

Experimental group

Description:

Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml) No exercise program

Treatment:

Drug: LowT

HighT+Resistance Training

Experimental group

Description:

High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml) 1 year standard Progressive Resistance Training(PRT) program

Treatment:

Behavioral: Resistance Training

Drug: HighT

HighT+No Resistance Training

Experimental group

Description:

High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml) No exercise program

Treatment:

Drug: HighT

Placebo+Resistance Training

Active Comparator group

Description: