DARK STUDY "DysbetalipoproteinemiA and atheRoma Risk" | NCT01760265

Studies
DARK STUDY "DysbetalipoproteinemiA and atheRoma Risk"

NCT01760265

Sponsor

Hospices Civils de Lyon

Status

Unknown status

Last Update Posted

Jan 28, 2013Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Dysbetalipoproteinemia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2013Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Jan 2, 2013

First Submission Date that Met QC Criteria

Jan 3, 2013

First Posted Date

Jan 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2013

Last Update Posted Date

Jan 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Measurement of carotid intima-media by ultrasonography	Comparison with eventual previous examinations.	Day one : on the date of measurement
Measurement of ankle brachial index	Comparison with eventual previous examinations

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Dysbetalipoproteinemia patients with APOE2/E2 or heterozygous mutation (negative dominance) and hypercholesterolemia, ratio CT VLDL/Tg VLDL >0.40

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Philippe MOULIN, Pr	Contact	4 72 68 13 04	+33	philippe.moulin@chu-lyon.fr

Overall Officials

Name	Affiliation	Role
Philippe MOULIN, Pr	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospices Civils de Lyon - Groupement Hospitalier Est	Recruiting	Bron		69100	France

Condition Browse Module

MeSH Terms

ID	Term
D006952	Hyperlipoproteinemia Type III

Ancestor Terms

ID	Term
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided