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

Completed

• Conditions: Diabetes; Metabolic Syndrome
• Interventions: Procedure: Blood sample

• Registration Number: NCT00932087
• Lead Sponsor: Hospices Civils de Lyon

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-07-01
• Study First Posted: 2009-07-02
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-12
• Last Update Posted: 2010-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
type 2 diabetics with metabolic syndrome	Blood sample	-
metabolic syndrome without diabetes	Blood sample	-
type 1 diabetes	Blood sample	-
control	Blood sample	-

Primary Outcome Measures

Name	Time	Method
Level of plasma isoprostane and lipoperoxides	at baseline

Secondary Outcome Measures

Name	Time	Method
TXA2 and PF4 levels after platelet activation of control platelet exposed to LDL	2 hours

Trial Locations

Locations (1)

Fédération d'Endocrinologie-Diabétologie-Maladies métaboliques-Nutrition - Hôpital Cardiovasculaire et Pneumologique; 🇫🇷 Lyon Cedex 03, France