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View Clinical Trial (Medical Research Study)
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Characteristics of Prader-Willi Syndrome and Early-Onset Morbid Obesity - NCT00375089-66160 (Clinical Trial 149408)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy149408.aspx
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| City: |
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Kansas City |
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State:
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KS |
| Zip Code: |
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66160 |
| Conditions: |
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Prader-Willi Syndrome - Obesity |
| Purpose: |
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Prader-Willi syndrome (PWS) is a rare genetic disorder that affects about 1 in 14,000 people
in the United States. As the most commonly identified genetic cause of obesity, PWS is
often confused with Early-onset Morbid Obesity (EMO). Individuals with EMO show some signs
of PWS, but clinically do not have PWS. The purpose of this study is to evaluate the
clinical features and genetic basis of PWS and EMO, and to determine how these conditions
affect a person throughout a lifetime.
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| Study summary: |
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PWS is a complex neurobehavioral syndrome. Clinical features include obesity, increased
appetite, low muscle tone, cognitive impairment, distinct behavioral features, hypogonadism,
and neonatal failure-to-thrive. It is the most commonly recognized genetic cause of
obesity; however, many obese children do not in fact have PWS. These individuals are
therefore diagnosed with EMO, a condition that shares features with PWS. The development of
new advances and strategies for treating PWS and EMO requires a thorough understanding of
the conditions at both the clinical and molecular levels. One goal of this study is to
collect long-term data on individuals with PWS and EMO in order to gain a better
understanding of the natural progression of the conditions, from the neonatal period well
into adulthood. Specific to PWS, this study will establish a genotype-phenotype correlation
among the different sub-types and will evaluate the effects of growth hormone treatment on
disease progression. Lastly, the study will compare PWS with EMO in terms of clinical
features and genetic basis.
Participation in this natural history study will entail an initial evaluation, followed by
yearly study visits until the age of 3 and then every 2 years thereafter. Each study visit
will last between 3 and 4 hours, and will include a physical exam (including a DEXA scan to
determine body composition), psychological testing, an interview with the study physician,
and an evaluation of the participant's diet history. In addition, blood tests will be
completed for genetic testing and photos will be taken to evaluate disease progression.
Cognitive and behavioral assessments will also be conducted and will last between 10 and 30
minutes. |
| Criteria: |
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Inclusion Criteria:
- Individuals enrolling in the Prader-Willi syndrome group will have a confirmed
diagnosis of Prader-Willi syndrome, as confirmed by molecular and cytogenetic testing
- Individuals enrolling in the Early-onset Morbid Obesity group will have a documented
medical history of their weight exceeding 150% of the ideal body weight or a body
mass index greater than 97% before the age of 4 years; they will also be under the
age of 30 years.
Exclusion Criteria:
- Known genetic, chromosomal, or hormonal cause of cognitive impairment other than
Prader-Willi syndrome |
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| Study is available at: |
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Kansas University Medical Center
Kansas City, KS 66160
United States
Primary Contact:
Merlin G. Butler, MD, PhD, FFACMG
Email: mbutler4@kumc.edu
Phone: 913-588-1800 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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