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

Diabetes Clinical Trial

— ECLIPSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932087
• Other study ID #: 2008.516
• Status: Completed
• Phase: N/A
• First received: June 22, 2009
• Last updated: April 12, 2010
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: April 2010
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Procedure:
• Blood sample
Blood sample for lipidomic study

Locations

Country	Name	City	State
France	Fédération d'Endocrinologie-Diabétologie-Maladies métaboliques-Nutrition - Hôpital Cardiovasculaire et Pneumologique	Lyon Cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of plasma isoprostane and lipoperoxides		at baseline	No
Secondary	TXA2 and PF4 levels after platelet activation of control platelet exposed to LDL		2 hours	No