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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00474643
Other study ID # 2006-06-043
Secondary ID
Status Completed
Phase N/A
First received May 10, 2007
Last updated May 15, 2007
Start date August 2006
Est. completion date December 2006

Study information

Verified date May 2007
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

Main outcome measures: Correlation of IMT with age, standard deviation score of BMI (BMI-SDS), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), C-reactive protein, HOMA-IR and ghrelin.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria:

- Prader Willi syndrome

- Children with obesity

Exclusion Criteria:

- Acute illness

- On regular medications except growth hormone

Study Design

Observational Model: Case Control, Primary Purpose: Screening, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center
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