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Completed

NCT Number: NCT00112151

TEAM: 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.

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Key information

Conditions

Healthy Behavior Endocrine System Diseases Gonadal Disorders Hypogonadism Motor Activity

Age range

60 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LowT

Drug

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)during the first 12 weeks. Total exposure duration is 52 weeks.

Other names: Androgel

Resistance training

Behavioral

Weight training 45-60 minutes 3 times per week

Other names: PRT, Progressive resistance training

Placebo

Drug

2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.

HighT

Drug

High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks.

Other names: Androgel

Primary outcomes

  1. Physical Function (CS-PFP Total Score)

    Time frame: Baseline and 12 months

    Continuous-scale physical function performance test (CS-PFP) which comprises 15 everyday tasks requiring upper and lower body strength and flexibility, balance, coordination and endurance. The CS-PFP was developed to measure performance in higher functioning adults with minimal floor or ceiling effects, and is valid, reliable and sensitive to change. Total and domain scores are scaled from 0 to 100, with higher scores indicating better function.

Secondary outcomes

  1. Upper Body Muscle Strength (1-RM, kg)

    Time frame: Baseline and 12 months

    The maximal weight a participant could lift once (1-repetition maximum, 1-RM) was assessed at baseline and 12 months. The average of the difference from baseline in 4 upper-body 1-RM measures (bench press,incline press, overhead pull-down, and seated row) are represented.

  2. Lower Body Muscle Strength (1-RM, kg)

    Time frame: Baseline and 12 months

    The maximal weight a participant could lift once [1-repetition maximum, 1-RM] was assessed at baseline and 12 months. The average of the difference from baseline in 3 lower-body 1-RM measures (knee extension, knee flexion, and seated leg press)) are represented.

  3. Power (Power Rig, Watts)

    Time frame: Baseline and 12 months

    Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts).

  4. Fat Mass (kg)

    Time frame: Baseline and 12 months

    Total change in Fat mass (kg) as evaluated by DXA

  5. Fat Free Mass (kg)

    Time frame: Baseline and 12 months

    Total change in Fat free mass (kg) as evaluated by DXA

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Testosterone Supplementation and Exercise in Elderly Men

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
May 30, 2005
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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