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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
After randomization, patients will be treated by pioglitazone or rosiglitazone
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
Service Endocrinologie-diabétologie, Hôpital du Bocage CHU
Dijon, France
Action of glitazone on the endothelium-dependent vasodilatory effects of HDL lipoproteins
Time frame: 6 months
Effect of glitazone therapy on Phospholipase A2 level
Time frame: 6 months
Analyze the glycemic response to glitazones according to baseline clinical and biological characteristics
Time frame: 6 months
Look for possible differences between pioglitazone and rosiglitazone for their effects on HDL lipoproteins and phospholipase A2
Time frame: 6 months
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