Testosterone in Obese Men Trial
Phase 3
Recruiting
- Conditions
- Obese Middle-Aged and Older Men with Borderline Androgen DeficiencyTestosterone deficiency in ageing malesDiet and Nutrition - ObesityMetabolic and Endocrine - Other metabolic and endocrine disorders
- Registration Number
- ACTRN12605000283673
- Lead Sponsor
- PHIMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
BMI between 30-39.9 kg/m2 and WC equal to or greater than102cm, Serum total Testosterone <12nM.
Exclusion Criteria
Smokers, Significant medical condition, Sleep Apnoea, Contra-indications to Testosterone therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in visceral fat[After 52 weeks of intervention]
- Secondary Outcome Measures
Name Time Method Change in visceral fat[After 52 weeks of intervention];Body Composition (Total Body Fat Mass and Fat Free Mass)[At 0 and 52 weeks];Vascular Function (Pulse Wave Velocity)[At 0 and 52 weeks];Metabolic (Insulin Resistance and Lipid Profiles)[At 0, 26 and 52 weeks];Coagulation profiles [At 0, 6, 26, and 52 weeks.]