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

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00932932
First received: July 2, 2009
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  Purpose

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
Prader-Willi Syndrome

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Mercy Hospital Kansas City:

Estimated Enrollment: 36
Study Start Date: February 2009
Study Completion Date: August 2010
Groups/Cohorts
PWS not receiving Growth Hormone
Control subjects healthy or obese
PWS subjects starting Growth Hormone

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932932

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

No publications provided

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
Study First Received: July 2, 2009
Last Updated: June 23, 2011
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

ClinicalTrials.gov processed this record on June 18, 2013