TEAM: Testosterone Supplementation and Exercise in Elderly Men

Phase 2

Completed

• Conditions: Healthy
• Interventions: Drug: LowT; Behavioral: Resistance Training; Drug: HighT; Drug: Placebo

• Registration Number: NCT00112151
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-05-27
• Study First Submitted QC: 2005-05-27
• Study First Posted: 2005-05-30
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2015-11-04
• Results First Submitted QC: 2015-12-14
• Results First Posted: 2016-01-20
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 167

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
LowT+Resistance Training	LowT	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
LowT+Resistance Training	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
LowT+No Resistance training	LowT	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
HighT+Resistance Training	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
HighT+Resistance Training	HighT	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
HighT+No Resistance Training	HighT	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
Placebo+Resistance Training	Resistance Training	Placebo Group applies two 2.5 gm placebo packets 1 year standard Progressive Resistance Training(PRT) program
Placebo+Resistance Training	Placebo	Placebo Group applies two 2.5 gm placebo packets 1 year standard Progressive Resistance Training(PRT) program
Placebo+No Resistance Training	Placebo	Placebo group applies two 2.5 gm placebo packets No exercise program

Primary Outcome Measures

Name	Time	Method
Physical Function (CS-PFP Total Score)	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 Outcome Measures

Name	Time	Method
Lower Body Muscle Strength (1-RM, kg)	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.
Fat Free Mass (kg)	Baseline and 12 months	Total change in Fat free mass (kg) as evaluated by DXA
Upper Body Muscle Strength (1-RM, kg)	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.
Power (Power Rig, Watts)	Baseline and 12 months	Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts).
Fat Mass (kg)	Baseline and 12 months	Total change in Fat mass (kg) as evaluated by DXA

Trial Locations

Locations (1)

University of Colorado Health Sciences Center; 🇺🇸 Denver, Colorado, United States