Trial record 1 of 2 for:    Open Studies | "Hyperlipoproteinemia Type III"
Previous Study | Return to List | Next Study

DARK STUDY "DysbetalipoproteinemiA and atheRoma Risk"

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01760265
First received: January 2, 2013
Last updated: January 25, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760265

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

Locations
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
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 August 25, 2014