DARK STUDY "DysbetalipoproteinemiA and atheRoma Risk"
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Purpose
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 |
|---|
|
Dysbetalipoproteinemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Dysbetalipoproteinemia and Atheroma Risk : Assessment of Cardiovascular Risk in Dysbetalipoproteinemic Patients |
- Computed tomographic measurements for coronary-artery calcium [ Time Frame: Day one : the coronary calcium score is assessed on the date of measurement ] [ Designated as safety issue: Yes ]Comparison with eventual previous examinations.
- Measurement of carotid intima-media by ultrasonography [ Time Frame: Day one : on the date of measurement ] [ Designated as safety issue: Yes ]Comparison with eventual previous examinations.
- Measurement of ankle brachial index [ Time Frame: Day one : on the date of measurement ] [ Designated as safety issue: Yes ]Comparison with eventual previous examinations
Biospecimen Retention: Samples With DNA
Lipid, apo E genotype when is necessary to complete the phenotype
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Dysbetalipoproteinemia patients with APOE2/E2 or heterozygous mutation (negative dominance) and hypercholesterolemia, ratio CT VLDL/Tg VLDL >0.40
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| Contact: Philippe MOULIN, Pr | 4 72 68 13 04 ext +33 | philippe.moulin@chu-lyon.fr |
| 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 | |
| Principal Investigator: | Philippe MOULIN, Pr | Hospices Civils de Lyon |
More Information
No publications provided
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT01760265 History of Changes |
| Other Study ID Numbers: | 1 |
| Study First Received: | January 2, 2013 |
| Last Updated: | January 25, 2013 |
| Health Authority: | France: French Data Protection Authority |
Keywords provided by Hospices Civils de Lyon:
|
dysbetalipoproteinemia artery calcium score carotid intima media ankle brachial index dysbetalipoproteinemic patients |
Additional relevant MeSH terms:
|
Hyperlipoproteinemia Type III Plaque, Atherosclerotic Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias |
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 21, 2013