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

This study has been completed.
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00932087
First received: June 22, 2009
Last updated: April 12, 2010
Last verified: April 2010
History of Changes
  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: 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

Resource links provided by NLM:

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 ]

Estimated Enrollment: 48
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: January 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:   30 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

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

No publications provided by Hospices Civils de Lyon

Additional 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
Study First Received: June 22, 2009
Last Updated: April 12, 2010
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on May 19, 2013