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Trial registered on ANZCTR


Registration number
ACTRN12615000600549
Ethics application status
Approved
Date submitted
21/05/2015
Date registered
9/06/2015
Date last updated
26/02/2019
Date data sharing statement initially provided
26/02/2019
Date results information initially provided
26/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of testosterone and exercise (TEX) on fitness, physical activity and vascular health in men.
Scientific title
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.
Secondary ID [1] 286777 0
Nil
Universal Trial Number (UTN)
U1111-1170-4352
Trial acronym
TEX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fitness 295156 0
Physical activity 295157 0
Overweight
Vascular health
295158 0
Condition category
Condition code
Cardiovascular 295393 295393 0 0
Diseases of the vasculature and circulation including the lymphatic system
Diet and Nutrition 295447 295447 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.







Intervention code [1] 291935 0
Treatment: Drugs
Intervention code [2] 291936 0
Behaviour
Intervention code [3] 291980 0
Lifestyle
Comparator / control treatment
Arm 4: Placebo and usual activities
Control group
Placebo

Outcomes
Primary outcome [1] 295133 0
Cardiorespiratory fitness measured using a treadmill protocol and indirect calorimetry.
Timepoint [1] 295133 0
12 weeks
Primary outcome [2] 295134 0
Physical activity will be assessed using a compact heart rate monitor with an integrated uni-axial accelerometer.
Timepoint [2] 295134 0
Monitor will be worn for seven days in week 12
Secondary outcome [1] 314828 0
Ambulatory blood pressure will be measured over 24 hours using an automated portable monitor.
Timepoint [1] 314828 0
12 weeks
Secondary outcome [2] 314829 0
Arterial stiffness will be assessed using piezoelectric-based sensors placed on the carotid and femoral arteries.
Timepoint [2] 314829 0
12 weeks
Secondary outcome [3] 314830 0
Endothelial function will be assessed in the brachial and femoral arteries in response to application and release of an occlusive pressure cuff, and also in response to a single dose of glyceryl trinitrate (GTN), using non-invasive high resolution Duplex ultrasound. The dose of GTN is 400 µg administered by sub-lingual spray.
Timepoint [3] 314830 0
12 weeks
Secondary outcome [4] 314831 0
Body composition will be assessed using Dual Energy X-ray Absorptiometry.
Timepoint [4] 314831 0
12 weeks

Eligibility
Key inclusion criteria
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.
Minimum age
50 Years
Maximum age
70 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be based on random numbers, with participants assigned unique study ID numbers. These ID numbers will appear on the labelling of the drug, with no indication of whether the allocated drug is testosterone or placebo. Allocation will be concealed by the use of sealed opaque envelopes, with the holder of the allocation schedule being off site and contacted by telephone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised-block randomisation was used for subject allocation in order to ensure similar numbers of subjects within each group. Blocks of four and eight were randomly selected and simple randomisation within blocks occurred. The user-written ‘ralloc’ package was used based upon Stata software (Version 13, StataCorp, College Station, Tx., USA).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Factorial
Other design features
With regard to receiving and administering treatments, the blinding refers to the testosterone vs placebo arms, not the exercise intervention.
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Treatment effects of T and exercise will be examined using general linear modelling adjusted for baseline variables. Based on our previous studies involving centre-based exercise training in 182 subjects, the planned sample sizes will allow detection of a clinically significant difference in VO2peak of 2.5 ml/kg/min with 80% power at a=0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3817 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 9711 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 291322 0
Charities/Societies/Foundations
Name [1] 291322 0
Heart Foundation (Australia)
Address [1] 291322 0
Level 12, 500 Collins Street, Melbourne, VIC 3000.
Country [1] 291322 0
Australia
Primary sponsor type
Individual
Name
Dr Bu Yeap
Address
School of Medicine and Pharmacology, M582, University of Western Australia, 35 Stirling Highway, Crawley, WA 6009
Country
Australia
Secondary sponsor category [1] 290007 0
University
Name [1] 290007 0
University of Western Australia, School of Medicine and Pharmacology, Fiona Stanley Hospital Unit
Address [1] 290007 0
Harry Perkins Institute of Medical Research, Fiona Stanley Hospital, Robin Warren Drive, Murdoch, WA 6150
Country [1] 290007 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292886 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 292886 0
Harry Perkins Institute of Medical Research, Fiona Stanley Hospital, Robin Warren Drive, Murdoch, WA 6150
Ethics committee country [1] 292886 0
Australia
Date submitted for ethics approval [1] 292886 0
Approval date [1] 292886 0
12/05/2015
Ethics approval number [1] 292886 0
15/21

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57502 0
Prof Bu Yeap
Address 57502 0
Harry Perkins Institute of Medical Research, Fiona Stanley Hospital, Robin Warren Drive, Murdoch, WA 6150
Country 57502 0
Australia
Phone 57502 0
+61 8 6151 1149
Fax 57502 0
Email 57502 0
bu.yeap@uwa.edu.au
Contact person for public queries
Name 57503 0
Ms Chyn Soh
Address 57503 0
Harry Perkins Institute of Medical Research, Fiona Stanley Hospital, Robin Warren Drive, Murdoch, WA 6150
Country 57503 0
Australia
Phone 57503 0
+61 8 6151 1138
Fax 57503 0
Email 57503 0
shuen-chyn.soh@uwa.edu.au
Contact person for scientific queries
Name 57504 0
Prof Bu Yeap
Address 57504 0
Harry Perkins Institute of Medical Research, Fiona Stanley Hospital, Robin Warren Drive, Murdoch, WA 6150
Country 57504 0
Australia
Phone 57504 0
+61 8 6151 1149
Fax 57504 0
Email 57504 0
bu.yeap@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant confidentiality.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary