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
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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 |
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Dysbetalipoproteinemia |
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 |

- 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.
- Measurement of carotid intima-media by ultrasonography [ Time Frame: Day one : on the date of measurement ]Comparison with eventual previous examinations.
- Measurement of ankle brachial index [ Time Frame: Day one : on the date of measurement ]Comparison with eventual previous examinations
Biospecimen Retention: Samples With DNA

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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 |
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

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
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 |
Responsible Party: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT01760265 |
Other Study ID Numbers: |
1 |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | January 28, 2013 |
Last Verified: | January 2013 |
dysbetalipoproteinemia artery calcium score carotid intima media ankle brachial index dysbetalipoproteinemic patients |
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 |