Type 2 Diabetes Clinical Trial
Official title:
Influence of Glitazones on the Vasodilatory Effect of HDL Lipoproteins and on Phospholipase A2
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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