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

This study is currently recruiting participants.

Verified by Children's Mercy Hospital Kansas City, July 2009

First Received: July 2, 2009 Last Updated: July 7, 2009 History of Changes

Sponsored by:	Children's Mercy Hospital Kansas City
Information provided by:	Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT00932932

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:	Case Control, 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:

Genetics Home Reference related topics: Prader-Willi syndrome

MedlinePlus related topics: Prader-Willi Syndrome

U.S. FDA Resources

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	36
Study Start Date:	February 2009

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

Contacts

Contact: Jill D Jacobson, MD	816/234-1660	jjacobson@cmh.edu
Contact: Dee Spade, DO	816/234-1660	dspade@cmh.edu

Locations

United States, Missouri
Children's Mercy Hospital	Recruiting
Kansas City, Missouri, United States, 64108
Principal Investigator: Jill D Jacobson, MD

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

Investigators

Principal Investigator:

Jill D Jacobson, MD

Children's Mercy Hospital Kansas City

More Information

No publications provided

Responsible Party:	Children's Mercy Hospitals and Clinics ( Jill Jacobson,MD )
Study ID Numbers:	09 01-014
Study First Received:	July 2, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00932932 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Obesity
Hydrocortisone
Cortisol succinate
Chromosome Disorders
Healthy
Mental Retardation
Genetic Diseases, Inborn
Abnormalities, Multiple

Neurologic Manifestations
Nutrition Disorders
Overnutrition
Hydrocortisone acetate
Prader-Willi Syndrome
Congenital Abnormalities
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Obesity
Disease
Nervous System Diseases
Chromosome Disorders
Mental Retardation
Pathologic Processes
Genetic Diseases, Inborn
Syndrome

Abnormalities, Multiple
Neurologic Manifestations
Nutrition Disorders
Overnutrition
Prader-Willi Syndrome
Congenital Abnormalities
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on September 10, 2009