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DARK STUDY "DysbetalipoproteinemiA and atheRoma Risk" (DARK)

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ClinicalTrials.gov Identifier: NCT01760265
Recruitment Status : Unknown
Verified January 2013 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : January 4, 2013
Last Update Posted : January 28, 2013
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief 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.


Condition or disease
Dysbetalipoproteinemia

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dysbetalipoproteinemia and Atheroma Risk : Assessment of Cardiovascular Risk in Dysbetalipoproteinemic Patients
Study Start Date : January 2013
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Computed tomographic measurements for coronary-artery calcium [ Time Frame: Day one : the coronary calcium score is assessed on the date of measurement ]
    Comparison with eventual previous examinations.


Secondary Outcome Measures :
  1. Measurement of carotid intima-media by ultrasonography [ Time Frame: Day one : on the date of measurement ]
    Comparison with eventual previous examinations.

  2. Measurement of ankle brachial index [ Time Frame: Day one : on the date of measurement ]
    Comparison with eventual previous examinations


Biospecimen Retention:   Samples With DNA
Lipid, apo E genotype when is necessary to complete the phenotype

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Dysbetalipoproteinemia patients with APOE2/E2 or heterozygous mutation (negative dominance) and hypercholesterolemia, ratio CT VLDL/Tg VLDL >0.40
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760265


Contacts
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Contact: Philippe MOULIN, Pr 4 72 68 13 04 ext +33 philippe.moulin@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon - Groupement Hospitalier Est Recruiting
Bron, France, 69100
Contact: Philippe MOULIN    4 72 68 13 04 ext +33    Philippe.moulin@chu-lyon.fr   
Principal Investigator: Philippe MOULIN, Pr         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Philippe MOULIN, Pr Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01760265     History of Changes
Other Study ID Numbers: 1
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013
Keywords provided by Hospices Civils de Lyon:
dysbetalipoproteinemia
artery calcium score
carotid intima media
ankle brachial index
dysbetalipoproteinemic patients
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type III
Plaque, Atherosclerotic
Pathological Conditions, Anatomical
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
 Hyperlipoproteinemias
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases