Growth Hormone Use in Adults With Prader-Willi Syndrome
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Children's Mercy Hospital Kansas City.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Children's Mercy Hospital Kansas City
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00444964
First received: March 6, 2007
Last updated: March 7, 2007
Last verified: March 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prader-Willi Syndrome |
Drug: Nutropin AQ |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Growth Hormone Use in Adults With Prader-Willi Syndrome |
Resource links provided by NLM:
Further study details as provided by Children's Mercy Hospital Kansas City:
Primary Outcome Measures:
- 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
| Estimated Enrollment: | 10 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | February 2007 |
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.
Eligibility| Ages Eligible for Study: | 16 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444964
Locations
| United States, Missouri | |
| The Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Merlin G Butler, MD 816-234-3290 mgbutler@cmh.edu | |
| Contact: Wayne Moore, MD 816-234-3844 wmoore@cmh.edu | |
| Principal Investigator: Merlin G Butler, MD | |
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
| Principal Investigator: | Merlin G Butler, MD | The Children's Mercy Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00444964 History of Changes |
| Other Study ID Numbers: | 303-C02R |
| Study First Received: | March 6, 2007 |
| Last Updated: | March 7, 2007 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Prader-Willi Syndrome Mental Retardation Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders |
Genetic Diseases, Inborn Obesity Overnutrition Nutrition Disorders Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013