Global Growth hormone study in Adults with Prader-Willi Syndrome
- Conditions
- Prader-Willi Syndrome
- Registration Number
- NL-OMON27149
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
The patient is diagnosed with PWS
- The patient is 30 years or older
- GH therapy was suspended at least three years before starting the study
Exclusion Criteria
- Non cooperative behaviour
- Known malignancies
- Poorly controlled diabetes (HbA1c > 64 mmol/mol (8%))
- Untreated obstructive sleep apnea (apnea-hypopnea index > 5)
- BMI above 40 kg/m2
- Osteosynthesis material
- Testosterone suppletion is not stable for three months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is change in lean body mass (LBM (kg)) as assessed by Dual Energy X-ray Absorptiometry (DEXA) scan
- Secondary Outcome Measures
Name Time Method Secondary endpoints are total fat mass, bone density, physical health, endurance, psychosocial functioning and quality of life.