Prader-Willi Syndrome
Conditions
Interventions
Participants will be randomized to placebo or growth hormone treatment for one year. After a washout period of 3 months, the patients who received placebo during the first year will be switched to gro
Sponsors
Erasmus Medical Center
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is change in lean body mass (LBM (kg)) as assessed by Dual Energy X-ray Absorptiometry (DEXA) scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are total fat mass, bone density, physical health, endurance, psychosocial functioning and quality of life. | — |
Contacts
Public ContactAnna Rosenberg
Erasmus University Medical Center, Rotterdam
Outcome results
None listed