Effect of Pioglitazone on Intima Media Thickness, Endothelial Function, and Heart Rate Variability in Patients With Impaired Glucose Tolerance
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 120
- 试验地点
- 14
- 主要终点
- Change in intima media thickness of carotid artery
研究概览
简要总结
In patients with impaired glucose tolerance (IGT), the researchers want to study the relative effects of pioglitazone, simvastatin, or the combination of both on:
- intima media thickness (IMT) as an easily assessed marker of atherosclerosis
- heart rate variability (HRV) as a marker of autonomic neuropathy
- flow-mediated vasodilatation (FMD) of the brachial artery as a marker of endothelial function
- vascular and metabolic lab parameters
详细描述
We want to study the relative effects of pioglitazone, simvastatin or the combination of both on intima media thickness (IMT), heart rate variability (HRV), flow-mediated vasodilatation (FMD) of the brachial artery and vascular/metabolic lab parameters in patients with impaired glucose tolerance (IGT). Previous studies have shown a reduction in IMT for both pioglitazone and simvastatin in type 2 diabetics. Many patients with diabetes mellitus develop diabetic polyneuropathy which can be assessed by measuring HRV. It has been shown that pioglitazone has a positive effect on HRV in type 2 diabetics. Questions remain on the relative efficacy of pioglitazone and simvastatin on the parameters mentioned above. Also, there is only scarce data in patients with IGT (as opposed to overt diabetes mellitus). There are no data on the relative effects of pioglitazone and simvastatin on flow-mediated vasodilatation (FMD) of the brachial artery as a surrogate marker for endothelial function.
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
- Double
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Impaired glucose tolerance
- •Age 40 to 75 years
排除标准
- •Diabetes mellitus type 1 or 2
- •Hypersensitivity to study medication
- •Malignant tumor
- •Alcohol or drug abuse
- •Overt heart failure
- •Severe hepatic, renal, neurological, psychiatric, or hematological disease
- •Prior treatment with glitazones or statins
- •Established indication for statin treatment (e.g. coronary artery disease [CAD])
结局指标
主要结局
Change in intima media thickness of carotid artery
次要结局
- Heart rate variability
- Flow-mediated dilatation of brachial artery
- Vascular/metabolic lab parameters