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

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ClinicalTrials.gov Identifier: NCT00932087
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : April 13, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Diabetes Metabolic Syndrome Procedure: Blood sample

Study Design

Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characterization of Low Density Lipoprotein and Mechanism of the Pro Aggregant Effect Through Oxidant Stress and Lipid Exchange
Study Start Date : February 2009
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Level of plasma isoprostane and lipoperoxides [ Time Frame: at baseline ]

Secondary Outcome Measures :
  1. TXA2 and PF4 levels after platelet activation of control platelet exposed to LDL [ Time Frame: 2 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

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): NCT00932087


Locations
France
Fédération d'Endocrinologie-Diabétologie-Maladies métaboliques-Nutrition - Hôpital Cardiovasculaire et Pneumologique
Lyon Cedex 03, France, 69394
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Philippe MOULIN, MD, PhD Hospices Civils de Lyon
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philippe MOULIN, MD PhD, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00932087     History of Changes
Other Study ID Numbers: 2008.516
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: April 13, 2010
Last Verified: April 2010

Keywords provided by Hospices Civils de Lyon:
Platelet function
diabetes
metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases