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.
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. 1. 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. 2. Improvement in quality of life measures as indicated by ratings on established behavior checklists in participants. 3. Changes in body composition (decreased fat, increased lean body mass and bone density) as determined by DEXA in participants. 4. 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
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
11
0.0125 mg/kg/day
The Children's Mercy Hospital
Kansas City, Missouri, United States
Body Composition
Anthropometric Measures and Body Composition
Time frame: 12 and 24 months
Blood Chemistry
Insulin-like growth factor I- IGF-1
Time frame: 12 and 24 months
Physical Activity
Duration of daily physical activity
Time frame: 12 and 24 months
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