CompletedPhase 3ACTRN12615000600549

Effects of testosterone and exercise (TEX) on fitness, physical activity and vascular health in men.

Effects of testosterone and exercise (TEX) on fitness, physical activity and vascular health in men aged 50-70 years with waist circumference 95 cm or more: a 2x2 factorial randomised controlled trial.

Sponsor

Dr Bu Yeap

Enrollment

80 participants

Start Date

Mar 30, 2016

Study Type

Interventional

Conditions

Overweight Vascular health Fitness

Summary

This will be a 12 week, 2x2 factorial randomised controlled trial of the effect of testosterone treatment, with and without exercise training, on cardiorespiratory fitness, physical activity levels and vascular health and physiology (validated markers of cardiovascular risk) in men aged 50-70 years who have waist circumference 95 cm or more. The hypothesis is that 12 weeks of testosterone plus exercise training will produce additive beneficial effects on fitness, physical activity and measures of vascular physiology, compared to either intervention alone, or placebo. These results would inform the debate over the risks and benefits of testosterone therapy in men.

Eligibility

Sex: MalesMin Age: 50 YearssMax Age: 70 Yearss

Inclusion Criteria1

Men aged 50-70 years with waist circumference 95 cm or more. Total cholesterol 7.0 mmol/L or less, or LDL 4.0 mmol/L or less, eGFR 45 ml/min or more, and total testosterone 6-14 nmol/L with normal haematocrit and PSA, and no evidence of significant liver disease. No clinical indication of pituitary, testicular or prostate disease, and office BP 150 mmHg systolic or less and 95 mmHg diastolic or less.

Exclusion Criteria1

Cardiovascular disease shown by history of angina, hospitalisation for myocardial infarction, stroke, heart failure or peripheral artery disease, prostate cancer or other major medical comorbidity (eg. renal or lung disease or cancer, transplantation or use of high dose opiate therapy).

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Interventions

Arm 1: Testosterone supplementation and exercise training Arm 2: Testosterone supplementation and usual activities Arm 3: Placebo and exercise training Testosterone dose: 5% w/v testosterone crea

Arm 1: Testosterone supplementation and exercise training Arm 2: Testosterone supplementation and usual activities Arm 3: Placebo and exercise training Testosterone dose: 5% w/v testosterone cream, 2 ml applied transdermally every morning for 12 weeks. Used tubes will be collected and weighed to verify amounts applied. Participants will be provided with a diary to record doses. Exercise training will involve one hour of exercise at least twice, if possible three times per week, for 12 weeks. Each session will consist 15 minutes of warm up and cool down exercises, and 45 minutes of an exercise circuit with a series of stations incorporating aerobic and resistance exercise. Treadmill and cycle ergometers and multigym weights will be used. Exercise will commence at 65% and progress up to 80% of baseline VO2 max or strength for aerobic and resistance exercise respectively. Training will be administered in small group sessions supervised by an exercise physiologist. A record of attendance will be kept. For Arm 1, both interventions commence and contunue over the same period.