Growth Hormone Use in Adults With Prader-Willi Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00444964|
Recruitment Status : Completed
First Posted : March 8, 2007
Results First Posted : January 8, 2021
Last Update Posted : January 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prader-Willi Syndrome||Drug: Nutropin AQ||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Growth Hormone Use in Adults With Prader-Willi Syndrome|
|Actual Study Start Date :||April 2005|
|Actual Primary Completion Date :||January 1, 2012|
|Actual Study Completion Date :||January 1, 2012|
Experimental: Primary Cohort
Drug: Nutropin AQ
Other Name: Growth Hormone
- Body Composition [ Time Frame: 12 and 24 months ]Anthropometric Measures and Body Composition
- Blood Chemistry [ Time Frame: 12 and 24 months ]Insulin-like growth factor I- IGF-1
- Physical Activity [ Time Frame: 12 and 24 months ]Duration of daily physical activity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444964
|United States, Missouri|
|The Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Merlin G Butler, MD||Children's Mercy Hospital Kansas City|