None listed
Conditions
Brief summary
This is a randomised placebo-controlled trial of testosterone undecanoate in obese men with obstructive slee apena as adjunctive therapy for a weight loss programme. The aim of the study is to evaluate the additional effect of testosterone replacement on weight loss and motivation in obese (BMI>30kg/m2) men with obstructive sleep apnea undergoing a weight reduction program. The primary endopint is weight loss after 4.5 months with other secondary endpoints including body composition, anthropometry, physical activity, metabolic markers (eg insulin sensitivity, basal metabolic rate) and blood hormone concentrations.
Interventions
This is a randomised placebo-controlled trial of testosterone undecanoate in obese men with obstructive slee apena (OSA) as adjunctive therapy for a weight loss programme.The study will be conducted on an ambulatory basis and involve OSA subjects who are about to commence a standard weight reduction program. Once deemed eligible for the study, at a Screening visit, patients will report to the laboratory every 6 weeks for 18 weeks. They will receive three injections of testosterone (3000mg in tot
This is a randomised placebo-controlled trial of testosterone undecanoate in obese men with obstructive slee apena (OSA) as adjunctive therapy for a weight loss programme.The study will be conducted on an ambulatory basis and involve OSA subjects who are about to commence a standard weight reduction program. Once deemed eligible for the study, at a Screening visit, patients will report to the laboratory every 6 weeks for 18 weeks. They will receive three injections of testosterone (3000mg in total) undecanoate at 0, 6 and 12 weeks. In addition, whilst reporting patients will undergo a variety of assessments including overnight polysomnographies at weeks 0, 6 and 18 weeks. Patient will then reassessed in recovery, at one year
Sponsors
The Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
No significant uncontrolled medical problems.
Exclusion criteria
Severe OSA ((minimum oxygen saturation < 65% or RDI > 80) requiring immediate treatment due to severity or increased associated risk (eg Transport worker), Use of drugs that alter androgen action, Contraindications to testosterone therapy, Desire for paternity within the next 12 months, Participation in sports that ban testosterone and require drug monitoring, Psychiatric disorders or drug abuse unless well controlled,Chronic medical conditions likely to interfere with or influence study treatment or safety unless well controlled.
Outcome results
None listed