NCT00658463

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	Rosuvastatin	rosuvastatin 20 mg/day during 6 weeks versus placebo during 6 weeks in a cross-over design
DRUG	Placebo	Placebo

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-06-01
• Completion: 2007-09-01
• First posted: 2008-04-15
• Last updated: 2008-04-15

Locations

1 site across 1 country: France