TEAM: Testosterone Supplementation and Exercise in Elderly Men

Condition(s) targeted: Healthy

Intervention: Testosterone Gel (Drug); Progressive Resistance Training (Behavioral); Placebo (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: University of Colorado, Denver

Official(s) and/or principal investigator(s):
Robert S. Schwartz, MD, Principal Investigator, Affiliation: University of Colorado, Denver

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.

Official title: Testosterone Supplementation and Exercise in Elderly Men

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Muscle Strength & Power, Physical Function, Body Composition, Vascular Health

Secondary outcome:

Blood chemistries

Transrectal ultrasound

Digital rectal exam

Obstructive sleep apnea

Maximal oxygen volume uptake

Benign prostatic hyperplasia

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.

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Generally healthy, untrained men over 60 years old 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

- Current smoker

University of Colorado Health Sciences Center, Denver, Colorado 80262, United States

Current Protocol

Analysis Plan for Primary Results

Testosterone Supplementation and Exercise in Elderly Men Abstract

Related publications:

Schwartz RS, Shuman WP, Bradbury VL, Cain KC, Fellingham GW, Beard JC, Kahn SE, Stratton JR, Cerqueira MD, Abrass IB. Body fat distribution in healthy young and older men. J Gerontol. 1990 Nov;45(6):M181-5.

Porter MM, Vandervoort AA, Lexell J. Aging of human muscle: structure, function and adaptability. Scand J Med Sci Sports. 1995 Jun;5(3):129-42. Review.

Jolles J, Verhey FR, Riedel WJ, Houx PJ. Cognitive impairment in elderly people. Predisposing factors and implications for experimental drug studies. Drugs Aging. 1995 Dec;7(6):459-79. Review.

Davidson JM, Chen JJ, Crapo L, Gray GD, Greenleaf WJ, Catania JA. Hormonal changes and sexual function in aging men. J Clin Endocrinol Metab. 1983 Jul;57(1):71-7.

Vitiello MV. Sleep disorders and aging: understanding the causes. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M189-91. Review.

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. Review. Erratum in: Neurosci Biobehav Rev 1996 Summer;20(2):I-IV.

Starting date: January 2005
Last updated: October 10, 2012