Status:
COMPLETED
Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Office of Rare Diseases (ORD)
Rare Diseases Clinical Research Network
Conditions:
Prader-Willi Syndrome
Obesity
Eligibility:
All Genders
Up to 60 years
Brief Summary
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 ...
Detailed Description
PWS is a complex neurobehavioral syndrome. Clinical features include obesity, increased appetite, low muscle tone, cognitive impairment, distinct behavioral features, hypogonadism, and neonatal failur...
Eligibility Criteria
Inclusion
- 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
- Known genetic, chromosomal, or hormonal cause of cognitive impairment other than Prader-Willi syndrome
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT00375089
Start Date
September 1 2006
End Date
January 1 2014
Last Update
September 22 2014
Active Locations (4)
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1
University of California at Irvine
Orange, California, United States, 92868
2
University of Florida
Gainesville, Florida, United States, 32610-0296
3
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37201