Global Growth Hormone Study in Adults With Prader-Willi Syndrome

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall objective of this study is to measure the effect of growth hormone treatment on physical and psychosocial health in adults of 30 years or older with Prader-Willi syndrome. Patients are randomized to placebo or growth hormone treatment during the first year. They will switch treatment during the second year, so that each participant receives one year of growth hormone treatment and one year of placebo (cross-over study). We hypothesize that growth hormone treatment will improve the physical and psychosocial health.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborators: Foundation for Prader-Willi Research; Pfizer; Prader-Willi Fonds

Criteria

Inclusion Criteria:

• The patient is diagnosed with Prader-Willi syndrome (genetically confirmed)

• The patient is 30 years or older

• In case of previous GH treatment (for example in trial setting), GH should be stopped at least three years before starting the study

• The patient is treated by a dietitian (caloric restriction) for at least three months

Exclusion Criteria:

• 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

• Change in testosterone or estrogen replacement therapy in the last three months prior to study