Influence of Glitazones on the Vasodilatory Effect of HDL Lipoproteins and on Phospholipase A2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Action of glitazone on the endothelium-dependent vasodilatory effects of HDL lipoproteins
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with type 2 diabetes treated by oral antidiabetic agents (except glitazones) and/or insulin
- •age> 18 years
- •HbA1c > 6.5%
排除标准
- •renal failure
- •heart failure
- •primary hyperlipidemia
- •pregnancy
- •treatment that may modify lipid metabolism (glucocorticoids, oestrogens, retinoids, HIV antiviral drugs)
研究组 & 干预措施
pioglitazone
treatment with pioglitazone (dose from 30 mg:day to 45 mg/day)
干预措施: pioglitazone (Drug)
rosiglitazone
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
干预措施: rosiglitazone (Drug)
结局指标
主要结局
Action of glitazone on the endothelium-dependent vasodilatory effects of HDL lipoproteins
时间窗: 6 months
次要结局
- Effect of glitazone therapy on Phospholipase A2 level(6 months)
- Analyze the glycemic response to glitazones according to baseline clinical and biological characteristics(6 months)
- Look for possible differences between pioglitazone and rosiglitazone for their effects on HDL lipoproteins and phospholipase A2(6 months)
研究者
Prof. Bruno Vergès
Professor
Centre Hospitalier Universitaire Dijon