Status:
NOT_YET_RECRUITING
Growth Hormone Study in Adults With Prader-Willi Syndrome
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Foundation for Prader-Willi Research
Prader-Willi Fonds
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
The overall objective of this study is to measure the effect of growth hormone (GH) treatment on physical and psychosocial health in adults with Prader-Willi syndrome. Adults with PWS who have not bee...
Detailed Description
OBJECTIVES: To measure the effect of GHt on physical and psychosocial health in adults with PWS. The primary endpoint is change in lean body mass (LBM (kg)) as assessed by Dual Energy X-ray Absorpti...
Eligibility Criteria
Inclusion
- The patient is diagnosed with Prader-Willi syndrome (genetically confirmed)
Exclusion
- Non cooperative behaviour
- Pregnancy
- Known malignancies
- Poorly controlled diabetes (HbA1c \> 64 mmol/mol (8%))
- Untreated obstructive sleep apnea (apnea-hypopnea index \> 5)
- Body mass index above 40 kg/m2
- Upper-airway obstruction of any cause
Key Trial Info
Start Date :
March 24 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04484051
Start Date
March 24 2023
End Date
October 1 2026
Last Update
February 16 2023
Active Locations (1)
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1
Erasmus MC, University Medical Center Rotterdam
Rotterdam, South Holland, Netherlands, 3015GD