DARK STUDY "DysbetalipoproteinemiA and atheRoma Risk"

Dysbetalipoproteinemia Clinical Trial

— DARK  

Official title:

Dysbetalipoproteinemia and Atheroma Risk : Assessment of Cardiovascular Risk in Dysbetalipoproteinemic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01760265
• Other study ID #: 1
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2013
• Last updated: January 25, 2013
• Start date: January 2013
• Est. completion date: June 2013

Study information

• Verified date: January 2013
• Source: Hospices Civils de Lyon
• Contact: Philippe MOULIN, Pr
• Phone: 4 72 68 13 04
• Email: philippe.moulin[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

Dysbetalipoproteinemia (type III, Fredrickson's classification) is a rare metabolic disorder. It results from a defect in the clearance of VLDL and chylomicron remnants due to homozygous APOE2 variants or heterozygous APOE mutations, and there is an elevated plasma cholesterol and triglycerides.

As a consequence of the derangements in lipoprotein metabolism, dysbetalipoproteinemia predispose to the premature development of atherosclerosis.

However among this population there is heterogeneity in development of cardiovascular complications and the determinants remain unclear actually.

The aim of the investigators study is to evaluate the intensity of clinical atherosclerosis, and identify its determinants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• apo E gene sequencing in CBE (Centre de Biologie Est / Hospices Civils de Lyon / France) laboratory in Lyon until December 2012

Exclusion Criteria:

• age < 40 years

• refused participation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dysbetalipoproteinemia
• Hyperlipoproteinemia Type III

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Groupement Hospitalier Est	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Computed tomographic measurements for coronary-artery calcium	Comparison with eventual previous examinations.	Day one : the coronary calcium score is assessed on the date of measurement	Yes
Secondary	Measurement of carotid intima-media by ultrasonography	Comparison with eventual previous examinations.	Day one : on the date of measurement	Yes
Secondary	Measurement of ankle brachial index	Comparison with eventual previous examinations	Day one : on the date of measurement	Yes