Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to study the effects of GH on body composition, lipid and glucose metabolism, physical performance and safety aspects in adults with PWS.The patients are randomized to either GH or placebo the first year of the study, subsequently followed by two years of GH treatment. the study is performed in Norway, Sweden and Denmark.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Collaborator: Novo Nordisk A/S
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Genetically verified PWS diagnosis (by methylation and FISH test.)

• Between 18 and 50 years old

• Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the treatment of the subject.)

Exclusion Criteria:

• Known or suspected allergy to GH preparation.

• Previous participation in this trial.

• GH treatment within the last 1 years

• Malignancy or other serious diseases (ex severe cardiovascular diseases, severe infections)

• Sexhormone treatment initiated within the last year

• Pregnancy

• Untreated respiratory impairment, untreated sleep apnoea or untreated respiratory infection.