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Cortisol Activity in Patients With Prader-Willi Syndrome and Healthy Controls

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ClinicalTrials.gov Identifier: NCT00932932
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City

Brief Summary:
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.

Condition or disease
Prader-Willi Syndrome

Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: 11 Beta Hydroxysteroid Dehydrogenase 1 (11-beta HSD 1) Activity in Patients With Prader-Willi Syndrome and in Healthy Controls
Study Start Date : February 2009
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
PWS not receiving Growth Hormone
Control subjects healthy or obese
PWS subjects starting Growth Hormone




Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Defined population
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932932


Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Wayne Moore, MD Children's Mercy Hospital Kansas City

Responsible Party: Jill Jacobson,MD, Children's Mercy Hospitals and Clinics
ClinicalTrials.gov Identifier: NCT00932932     History of Changes
Other Study ID Numbers: 09 01-014
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Syndrome
Prader-Willi Syndrome
Hyperphagia
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Signs and Symptoms, Digestive
Signs and Symptoms