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Growth Hormone Use in Adults With Prader-Willi Syndrome

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ClinicalTrials.gov Identifier: NCT00444964
Recruitment Status : Unknown
Verified March 2007 by Children's Mercy Hospital Kansas City.
Recruitment status was:  Recruiting
First Posted : March 8, 2007
Last Update Posted : March 8, 2007
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City

March 6, 2007
March 8, 2007
March 8, 2007
April 2005
Not Provided
  • 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
Same as current
No Changes Posted
Not Provided
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Growth Hormone Use in Adults With Prader-Willi Syndrome
Growth Hormone Use in Adults With Prader-Willi Syndrome
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Prader-Willi Syndrome
Drug: Nutropin AQ
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
10
Same as current
February 2007
Not Provided

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
Sexes Eligible for Study: All
16 Years to 60 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00444964
303-C02R
Yes
Not Provided
Not Provided
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Children's Mercy Hospital Kansas City
Not Provided
Principal Investigator: Merlin G Butler, MD The Children's Mercy Hospital
Children's Mercy Hospital Kansas City
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP