Growth Hormone Use in Adults With Prader-Willi Syndrome

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The main research question this protocol aims to answer is whether treatment with growth hormone will impact body composition, quality of life, and energy balance in PWS adults, and if there is a loss of effects after cessation of treatment for at least 12 months.

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

Details

• Lead Sponsor: Children's Mercy Hospital Kansas City
• Treatments: Hormones

Criteria

Inclusion Criteria:

• 16 to 60 years old

• Male or female with diagnosed Prader-Willi syndrome confirmed by genetic testing (e.g., mPCR)

• Low IGF-1 level (e.g.,≤25%) at baseline

• Ability to provide informed consent or availability of a suitable legally authorized representative

Exclusion Criteria:

• Pregnancy

• Previous treatment with growth hormone

• Uncontrolled endocrine disease, (i.e. diabetes or thyroid)

• History of severe scoliosis

• Heart disease

• Uncontrolled high blood pressure or history of stroke

• Morbid obesity (using PWS growth charts)

• Severe sleep apnea or known breathing difficulties/obstruction (as per history or diagnostic testing results