NCT00932932

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

First QC Date

July 2, 2009

Last Update Submit

June 23, 2011

Conditions

Prader-Willi Syndrome

Study Arms (3)

PWS not receiving Growth Hormone

Control subjects healthy or obese

PWS subjects starting Growth Hormone

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Defined population

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prader-Willi Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImprinting DisordersObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Wayne Moore, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 7, 2009

Study Start

February 1, 2009

Study Completion

August 1, 2010

Last Updated

June 27, 2011

Record last verified: 2011-06