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Clinical Trial: TEAM: Testosterone Supplementation and Exercise in Elderly Men
This study is currently recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Healthy | Drug: Testosterone Gel Behavior: Exercise | Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: Testosterone Supplementation and Exercise in Elderly Men
Secondary Outcomes: cognition; vascular reactivity; obstructive sleep apnea; testosterone; estradiol; dehydroepiandrosterone (DHEA); insulin-like growth factor I; insulin resistance
Expected Total Enrollment: 150
Study start: January 2005; Expected completion: December 2008
Last follow-up: May 2008; Data entry closure: December 2008
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.
Eligibility
Ages Eligible for Study: 60 Years and above, Genders Eligible for Study: Male
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- Generally healthy, untrained men over 60 years old with low-normal testosterone levels (200-350g/dL)
Exclusion Criteria:
- Trained
- Obstructive sleep apnea
- Prostate/breast cancer
- Severe LUTS (lower urinary tract symptoms)
- Unable to exercise safely
- severe obesity (>34 body mass index [BMI])
- Polycythemia
Location and Contact Information
Colorado
University of Colorado Health Sciences Center, Denver, Colorado, 80262, United States; Recruiting
Robert S. Schwartz, MD, Principal Investigator
Robert S. Schwartz, MD, Principal Investigator, University of Colorado
More Information
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. No abstract available.
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.
Record last reviewed: May 2005
Last Updated: May 27, 2005
Record first received: May 27, 2005
ClinicalTrials.gov Identifier: NCT00112151
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-31
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