Characterization of Low Density Lipoprotein and Mechanism of the Pro Aggregant Effect Through Oxidant Stress and Lipid Exchange - Full Text View

Characterization of Low Density Lipoprotein and Mechanism of the Pro Aggregant Effect Through Oxidant Stress and Lipid Exchange (ECLIPSE)

This study is currently recruiting participants.

Verified by Hospices Civils de Lyon, July 2009

First Received: June 22, 2009 Last Updated: July 1, 2009 History of Changes

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00932087

Purpose

Case control design: lipidomic study in 12 type 2 diabetics with metabolic syndrome, 12 metabolic syndrome without diabetes, 12 subjects with type 1 diabetes and 12 controls

Condition	Intervention
Diabetes Metabolic Syndrome	Procedure: Blood sample

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Characterization of Low Density Lipoprotein and Mechanism of the Pro Aggregant Effect Through Oxidant Stress and Lipid Exchange

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Lipids

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Level of plasma isoprostane and lipoperoxides [ Time Frame: at baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

TXA2 and PF4 levels after platelet activation of control platelet exposed to LDL [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	48
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
type 2 diabetics with metabolic syndrome	Procedure: Blood sample Blood sample for lipidomic study
metabolic syndrome without diabetes	Procedure: Blood sample Blood sample for lipidomic study
type 1 diabetes	Procedure: Blood sample Blood sample for lipidomic study
control	Procedure: Blood sample Blood sample for lipidomic study

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

group 1: type 2 diabetics with metabolic syndrome group 2: metabolic syndrome without diabetes group 3: subjects with type 1 diabetes group 4: controls

Criteria

Inclusion Criteria:

statin and fibrate Wash out for one week
HbA1c>7% and <12% (Arms 1 and 3)
HbA1c<6% (Arms 2 and 4)
Metabolic sd according NCEP III (3 out 4 criteria) (Arms 1 and 2)

Exclusion Criteria:

secondary CV prevention

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932087

Contacts

Contact: Philippe MOULIN, MD, PhD

philippe.moulin@chu-lyon.fr

Locations

France
Fédération d'Endocrinologie-Diabétologie-Maladies métaboliques-Nutrition - Hôpital Cardiovasculaire et Pneumologique	Recruiting
Lyon Cedex 03, France, 69394
Contact: Philippe MOULIN, MD, PhD philippe.moulin@chu-lyon.fr

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Philippe MOULIN, MD, PhD

Hospices Civils de Lyon

More Information

No publications provided

Responsible Party:	Hospices Civils de Lyon ( Philippe MOULIN, MD PhD )
Study ID Numbers:	2008.516
Study First Received:	June 22, 2009
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00932087 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Hospices Civils de Lyon:

Platelet function
diabetes
metabolic syndrome

Study placed in the following topic categories:

Diabetes Mellitus
Stress

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on September 10, 2009