Pioglitazone Regress Left Ventricular Mass in Type 2 Diabetes With Ischeamia Heart Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The changes of LVM
研究概览
简要总结
Cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to ischeamia heart disease (IHD). Most of the attention in treating IHD in type 2 diabetes is understandably directed toward treating coronary artery conditions. However there are other treatable culprits in these patients.
Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with IHD, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality than either multivessel coronary disease or impaired left ventricular function. Regression of LVH has been associated with an improved prognosis, independent of change in blood pressure (BP). Therefore, cardiovascular events and mortality in type 2 diabetes with IHD might will be reduced if we can find novel therapies to regress LVH.
Pioglitazone can improve atherosclerosis. Therefore, we hypothesied that pioglitazone can regress the left ventricular mass (LVM) in type 2 diabetes with IHD.Therefore, in this study, we will treat patients with pioglitazone, and we will also metformin as control.
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 (Participant, Investigator)
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
- •type 2 diabetes
- •aged 40~75 years old
排除标准
- •heart failure
- •renal failure
- •hypertension (>130/80 mmHg)
- •hemoglobin A1c 9%
研究组 & 干预措施
Pioglitazone group
Pioglitazone 15 mg/day will be given in this group for 9 months
干预措施: pioglitazone group (Drug)
Metformin group
Metformin 0.85 twice daily will be given in this group for 9 months as control.
干预措施: Metformin group (Drug)
结局指标
主要结局
The changes of LVM
时间窗: The LVM will be measured at baseline, 6 momth and 9 month
次要结局
- The changes of endothelial function(The endothelial function will be measured at baseline, 6 month and 9 month)
研究者
Xiang Guang-da
Pioglitazone regress the left ventricular mass in normotensive type 2 diabetic patients with ischeamia heart disease
Wuhan General Hospital of Guangzhou Military Command
