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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
  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:


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
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: 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:
Metabolic Syndrome X
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014