NCT00474643

Brief Summary

Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset obesity and endocrine dysfunction that leads to cardiovascular disability and early death within the first 3 decades of life.To assess the significance of risk factors for future disabilities, carotid artery intima-media thickness (IMT) was measured and correlated with known atherosclerotic risk factors in 27 children with PWS and 24 age-, sex-, and body mass index (BMI)-adjusted controls.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2006

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 17, 2007

Completed
Last Updated

May 17, 2007

Status Verified

May 1, 2007

First QC Date

May 10, 2007

Last Update Submit

May 15, 2007

Conditions

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Prader Willi syndrome
  • Children with obesity

You may not qualify if:

  • Acute illness
  • On regular medications except growth hormone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prader-Willi SyndromeObesity

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImprinting DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kyung Hoon Paik, M.D.

    Samsung Medical Center, Sungkyunkwan University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 17, 2007

Study Start

August 1, 2006

Study Completion

December 1, 2006

Last Updated

May 17, 2007

Record last verified: 2007-05