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Sponsors and Collaborators: |
Centre Hospitalier Universitaire Dijon AstraZeneca |
Information provided by: | Centre Hospitalier Universitaire Dijon |
ClinicalTrials.gov Identifier: | NCT00658463 |
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.
Condition | Intervention | Phase |
Diabetes |
Drug: Rosuvastatin Drug: Placebo |
Phase IV |
MedlinePlus related topics: | Cholesterol Diabetes |
ChemIDplus related topics: | Rosuvastatin Rosuvastatin calcium Cholest-5-en-3-ol (3beta)- |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Effects of Rosuvastatin on the, in Vivo, Kinetic of VLDL apoB, IDL apoB, LDL apoB and HDL apoA1, Using Stable Isotopes, in Type 2 Diabetic Patients |
Enrollment: | 8 |
Study Start Date: | January 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
The study is designed with a one-month steady state period with placebo then on a cross-over design with two 6-week periods of placebo or rosuvastatin (20 mg). An in vivo kinetic study will be performed at the end of each 6-week period.
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Drug: Rosuvastatin
rosuvastatin 20 mg/day during 6 weeks versus placebo during 6 weeks in a cross-over design
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2: Placebo Comparator
The study is designed with a one-month steady state period with placebo then on a cross-over design with two 6-week periods of placebo or rosuvastatin (20 mg). An in vivo kinetic study will be performed at the end of each 6-week period.
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Drug: Placebo
Placebo
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This is a randomized, double blinded, placebo-controlled, monocentric, cross-over study with two 6-week periods of placebo or rosuvastatin. Subjects will enter a one month placebo lead-in period after which they will be eligible for rosuvastatin 20 mg or placebo for two 6-week periods.
An in vivo kinetic study will be performed with stable isotopes (13C leucine) in type 2 diabetic patients (n=8) before and after a 6-week period of rosuvastatin (20mg) therapy. The study is design with a one-month steady state period with placebo then on a cross-over design with two 6-week periods of placebo or rosuvastatin (20 mg. An in vivo kinetic study will be performed at the end of each 6-week period.
The kinetic studies performed, in each patient, will assess the production rates and fractional rates of VLDL1-apoB, VLDL2-apoB, IDL-apoB, LDL-apoB and HDL-apoA-I.
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |||||
Centre Hospitalier Universitaire de Dijon | |||||
Dijon, France, 21000 |
Centre Hospitalier Universitaire Dijon |
AstraZeneca |
Principal Investigator: | Bruno Vergès, MD | Centre Hospitalier Universitaire de Dijon |
Responsible Party: | Centre Hospitalier Universitaire Dijon ( Prof. Bruno Vergès ) |
Study ID Numbers: | AFSSAPS 041348 |
First Received: | April 2, 2008 |
Last Updated: | April 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00658463 |
Health Authority: | France: Direction Générale de la Santé |
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