Cortisol Activity in Patients With Prader-Willi Syndrome and Healthy Controls
June 23, 2011 updated by: Children's Mercy Hospital Kansas City
11 Beta Hydroxysteroid Dehydrogenase 1 (11-beta HSD 1) Activity in Patients With Prader-Willi Syndrome and in Healthy Controls
The purpose of the study is to find out if people with Prader-Willi syndrome have a difference in the protein which changes inactive cortisone to the active stress hormone cortisol.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
36
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Defined population
Description
Inclusion Criteria:
- Prader-Willi syndrome confirmed by molecular testing, ages 6 months to adult
- Controls: Age-matched, sex-matched, developmentally normal, BMI-controlled healthy or obese subjects
Exclusion Criteria:
- PWS subjects without molecular confirmation of the diagnosis
- Subjects receiving glucocorticoid treatment within 3 months of evaluation
- Subjects receiving growth hormone within one year prior to analysis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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PWS not receiving Growth Hormone
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Control subjects healthy or obese
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PWS subjects starting Growth Hormone
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wayne Moore, MD, Children's Mercy Hospital Kansas City
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
July 2, 2009
First Submitted That Met QC Criteria
July 2, 2009
First Posted (Estimate)
July 7, 2009
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 23, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Congenital Abnormalities
- Overnutrition
- Nutrition Disorders
- Genetic Diseases, Inborn
- Intellectual Disability
- Abnormalities, Multiple
- Chromosome Disorders
- Obesity
- Syndrome
- Prader-Willi Syndrome
Other Study ID Numbers
- 09 01-014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.