NCT00953498

Influence of Glitazones on the Vasodilatory Effect of High-density Lipoprotein (HDL) Lipoproteins

Influence of Glitazones on the Vasodilatory Effect of HDL Lipoproteins and on Phospholipase A2

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

HDL from patients with type 2 diabetes show a significant reduction of their endothelium-dependent vasodilatory effect. The primary objective of the study is to analyze whether treatment with glitazones (pioglitazone and rosiglitazone)may improve the endothelium-dependent vasodilatory effect of HDL lipoproteins in patients with type 2 diabetes. The secondary objectives are: * to analyze the effect of glitazone treatment on phospholipase A2 * to look for possible differences between the effects of pioglitazone and those of rosiglitazone * to analyze the glycemic response to glitazone therapy according to clinical and biological baseline characteristics.

Detailed description

The study will be performed as follows: At baseline, before initiating glitazone treatment, clinical data will be recorded and blood samples will be obtained for biological measurements (blood glucose, HbA1c, total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, liver enzymes), phospholipase A2 measurement and the study of the vasodilatory effect of HDL particles.For this purpose, we will study,using rabbit aorta rings,the ability of HDL to suppress the inhibition of vasodilation that is induced by oxidised LDL. For all the patients included into the study, a treatment by pioglitazone (at an initial dose of 30 mg/day) or rosiglitazone (at an initial dose of 4 mg/day) will be given by randomization. A visit will be performed at week 12, in order to titrate the glitazone dose (up to 45 mg/day for pioglitazone, up to 8 mg/day for rosiglitazone)according to HbA1c level and values of self-monitoring blood glucose. At week 24, the last visit will take place. During this visit, clinical data will be recorded and blood samples will be obtained for biological measurements (blood glucose, HbA1c, total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, liver enzymes), phospholipase A2 measurement and the study of the vasodilatory effect of HDL particles.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	pioglitazone	After randomization, patients will be treated by pioglitazone or rosiglitazone
DRUG	rosiglitazone	treatment with rosiglitazone at a dose between 4mg and 8 mg/day

Timeline

• Start date: 2007-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2009-08-06
• Last updated: 2013-09-02

Locations

1 site across 1 country: France