Clinical Trial: Growth Hormone Use in Adults With Prader-Willi Syndrome
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Growth Hormone Use in Adults With Prader-Willi Syndrome
Brief 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.
Detailed 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. Specific outcomes to be evaluated are as follows:
• Increased IGF-1 as a function of human growth hormone dosage compared with baseline.
- Improvement of indicators or risk factors for co-morbid diseases [diabetes (by measuring insulin and glucose levels), cardiovascular disease (by measuring lipids and fatty acids), and pulmonary function] in participants.
- Improvement in quality of life measures as indicated by ratings on established behavior checklists in participants.
- Changes in body composition (decreased fat, increased lean body mass and bone density) as determined by DEXA in participants.
- Increased energy expenditure as determined by whole-room calorimeter measures (8 hour energy expenditure, RMR, TEF, mechanical work); diet records, physical activity monitors and strength measures.
Sponsor: Children's Mercy Hospital Kansas City
Current Primary Outcome:
- Increased IGF-1 as a function of human growth hormone dosage compared with baseline
- Improvement of indicators or risk factors for co-morbid diseases [diabetes (by measuring insulin and glucose levels), cardiovascular disease (by measuring lipids and fatty acids), and pulmonary function] in participants.
- Improvement in quality of life measures as indicated by ratings on established behavior checklists in participants.
- Changes in body composition (decreased fat, increased lean body mass and bone density) as determined by DEXA in participants.
- Increased energy expenditure as determined by whole-room calorimeter measures (8 hour energy expenditure, RMR, TEF, mechanical work); diet records, physical activity monitors and strength measures
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Children's Mercy Hospital Kansas City
Dates:
Date Received: March 6, 2007
Date Started: April 2005
Date Completion: February 2007
Last Updated: March 7, 2007
Last Verified: March 2007
