TEAM: Testosterone Supplementation and Exercise in Elderly Men

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00112151
First received: May 27, 2005
Last updated: October 10, 2012
Last verified: October 2012

May 27, 2005
October 10, 2012
January 2005
November 2010   (final data collection date for primary outcome measure)
Muscle Strength & Power, Physical Function, Body Composition, Vascular Health [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • body composition
  • fat distribution
  • strength
  • power
  • function
Complete list of historical versions of study NCT00112151 on ClinicalTrials.gov Archive Site
  • Blood chemistries [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Transrectal ultrasound [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]
  • Digital rectal exam [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Obstructive sleep apnea [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Maximal oxygen volume uptake [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]
  • Benign prostatic hyperplasia [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • cognition
  • vascular reactivity
  • obstructive sleep apnea
  • testosterone
  • estradiol
  • dehydroepiandrosterone (DHEA)
  • insulin-like growth factor I
  • insulin resistance
Not Provided
Not Provided
 
TEAM: Testosterone Supplementation and Exercise in Elderly Men
Testosterone Supplementation and Exercise in Elderly Men

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • Drug: Testosterone Gel
    2.5 gm gel packets applied once daily, titrated during the first 12 weeks to a maximum of 10 gm per day, total duration 52 weeks.
    Other Name: Androgel
  • Behavioral: Progressive Resistance Training
    Weight training 45-60 minutes 3 times per week
    Other Name: PRT
  • Drug: Placebo
    2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.
  • Experimental: LowT+Progressive Resistance Training

    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

    Interventions:
    • Drug: Testosterone Gel
    • Behavioral: Progressive Resistance Training
    • Drug: Placebo
  • Experimental: LowT+No Progressive resistance training

    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

    Intervention: Drug: Testosterone Gel
  • Experimental: HighT+Progressive Resistance Training

    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

    Interventions:
    • Drug: Testosterone Gel
    • Behavioral: Progressive Resistance Training
  • Experimental: HighT+No Progressive Resistance Training

    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

    Intervention: Drug: Testosterone Gel
  • Active Comparator: Placebo+Progressive Resistance Training

    Placebo Group applies two 2.5 gm placebo packets

    1 year standard Progressive Resistance Training(PRT) program

    Interventions:
    • Behavioral: Progressive Resistance Training
    • Drug: Placebo
  • Placebo Comparator: Placebo+No Progressive Resistance Training

    Placebo group applies two 2.5 gm placebo packets

    No exercise program

    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
167
August 2014
November 2010   (final data collection date for primary outcome measure)

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
Male
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00112151
02-1056, R01AG019339
Yes
University of Colorado, Denver
University of Colorado, Denver
National Institute on Aging (NIA)
Principal Investigator: Robert S. Schwartz, MD University of Colorado, Denver
University of Colorado, Denver
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP