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Effects of Rosuvastatin on the, in Vivo, Kinetic of apoB and apoA1, Using Stable Isotopes, in Type 2 Diabetic Patients

NCT00658463 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2008-04-15

No results posted yet for this study

Summary

Statins have been shown to reduce significantly the risk for cardiovascular events in patients with type 2 diabetes and statin therapy is largely recommended in this high cardiovascular risk population. However, a residual cardiovascular risk is observed in patients with type 2 diabetes treated by statins. This may be due to the fact that statins do not correct all lipid abnormalities associated with diabetic dyslipidaemia, such as hyperTG and low HDL-cholesterol.

Rosuvastatin is a statin which, in addition to its efficacy to reduce LDL-cholesterol, has been show to decrease significantly plasma triglycerides. However, the effects of rosuvastatin on triglyceride rich lipoproteins and HDL remains unknown. The purpose of this study is to analyze the effect rosuvastatin 20 mg on the metabolism of triglyceride rich lipoproteins and HDL in patients with Type 2 diabetes using and in vivo kinetic study of VLDL1-apoB,VLDL2-apoB,IDL-apoB and HDL-apoA1.

Conditions

Interventions

DRUG

Rosuvastatin

rosuvastatin 20 mg/day during 6 weeks versus placebo during 6 weeks in a cross-over design

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Principal Investigators

  • Bruno Vergès, MD · Centre Hospitalier Universitaire Dijon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-06-30
Completion
2007-09-30

Countries

  • France

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00658463 on ClinicalTrials.gov