NCT01479322

Brief Summary

Context: 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. Objectives: 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 Jan 2007

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

January 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

First QC Date

July 31, 2011

Last Update Submit

November 23, 2011

Conditions

Prader-Willi SyndromeObesity

Keywords

Intima-media thicknessGhrelinPrader-Willi syndrome

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The investigators studied twenty-seven children with PWS and 24 normal control subjects. The groups were adjusted for age, sex, and BMI.

You may qualify if:

  • obesity with PWS

You may not qualify if:

  • chronic disease

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

  • Dong-Kyu Jin, M.D

    Samsung Medical Center, Sungkyunkwan University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 31, 2011

First Posted

November 24, 2011

Study Start

January 1, 2007

Study Completion

July 1, 2007

Last Updated

November 24, 2011

Record last verified: 2011-11