The Role of Androgens in Angiogenesis and Endothelial Progenitor Cell Mobilisatio
- Conditions
- Cardiovascular effects of testosterone therapy in healthy men, specifically mobilisation and function of endothelial progenitor cells.Cardiovascular - Normal development and function of the cardiovascular system
- Registration Number
- ACTRN12607000363482
- Lead Sponsor
- Dr. Martin Ng, Royal Prince Alfred Hospital.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 40
Two age-stratified groups of healthy, ambulatory men, comprising: 1) twenty men = 35 years of age and; 2) twenty men = 60 years of age will be asked to participate in this study.
Men will be excluded from the study if they have diseases of the prostate requiring medical or surgical treatment or have chronic medical diseases or medications likely to interfere with safe participation in androgen therapy.Specific exclusion criteria:Patients will be excluded from the study if any of the following criteria is fulfilled:a) Prostate disease still requiring further medical or surgical treatment. Men with an isolated elevation of PSA or with a history of prostatectomy for benign prostatic hyperplasia may be entered with the agreement of their own or the study urologist. If any doubt, volunteer may only enter study after urological review.b) Currently significant, inadequately controlled chronic medical diseases likely to interfere with safe participation. This includes severe chronic renal & liver disease; unstable chronic pulmonary or cardiovascular disease (including within 6 months of myocardial infarction); uncontrolled or severe hypertension, hyperlipidemia, obstructive sleep apnoea or polycythemia; or cancer with poor prognosis. c) Medical conditions which interfere with evaluation of main study end-points. This includes neuromuscular or skeletal diseases which interfere with reliable mobility or dynamometry testing. Patients with type I diabetes mellitus may be included but will not undergo insulin clamp testing. d) Medications interfering with evaluation of study end-points or changes in dosage during the study. e) Disallowed drugs include, androgens or other sex steroids, anti-androgens, cimetidine, spironolactone, GnRH analogs.f) Allowed medication include fixed doses throughout the study period of bisphosphonates, calcitriol, vitamins, statins, antihypertensives, glucocorticoids, benzodiazepines, over-the-counter & non-prescription medications, herbal medications, aspirin, paracetamol, non-steroidal anti-inflammatory drugs, opiates, anticoagulants.g) History of drug or alcohol abuse or psychological disorders requiring regular psychotrophic medication (other than benzodiazepines).h) Any other condition likely in the judgement of the investigator that makes the patient unable to complete, or unsuitable or unsafe for, the study.i) Any medical condition which in the judgement of the Investigator and sponsor may interfere with the absorption, distribution, metabolism or excretion of the drug. j) Refusal or inability to comply with the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endothelial progenitor cell number in peripheral blood as quantitated by flow cytometric analysis for CD34+/KDR+ and CD34+/CD133+ cells, respectively. [At 1 week, 6 weeks and 12 weeks.]
- Secondary Outcome Measures
Name Time Method Endothelial progenitor cell (EPC) function as assessed by standardised in vitro assays of EPC proliferation, migration and angiogenesis. [At 1 week, 6 weeks and 12 weeks.]