Effects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transitio
Completed
- Conditions
- Prader-Willi Syndrome10029299
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
Inclusion Criteria
genetically confirmed diagnosis of Prader-Willi syndrome
treated with GH for at least 2 years
final height is reached or epiphysial fusion is complete
aged 18-24 years
Exclusion Criteria
non-cooperative behaviour
extremely low dietary intake of less than minimal required intake according to WHO
medication to reduce weight (fat)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess effects of GH-treatment versus placebo on<br /><br>- body composition<br /><br>- carbohydrate metabolism<br /><br>- psychosocial functioning<br /><br>- sleep-related breathing disorders<br /><br>- circulating lipids<br /><br>- blood pressure<br /><br>- development of psychiatric disorders</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To study the effects of GH-treatment versus placebo on thyroid hormone<br /><br>levels, IGF-I and IGF binding proteins, adiponectin, ghrelin.<br /><br>- To study compliance to the diet.<br /><br>- To study if certain bloodmarks are related to the development of psychiatric<br /><br>disorders</p><br>