The Metabolic Memorial Effect of Early Intensive Multifactorial Treatment in Diabetes
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The metabolic memory effect of endothelium-dependent arterial dilation
研究概览
简要总结
The endothelial dysfunction is the early event in atherosclerosis. The investigator previous study showed that impaired endothelial function exist in newly diagnosed type 2 diabetes. The investigators hypothesize that intensive multifactorial therapy including intensive blood control and intensive hypertension control as well as intensive blood lipids control of 1 year can improve vascular endothelial function. Moreover, the improvement of endothelial function maintains after 5 years or 10 years of intensive multifactorial therapy, called "Metabolic Memorial Effect of improvement of endothelial function".
详细描述
- We select 1000 patients with newly diagnosed type 2 diabetes. They are divided into two groups, respectively (Intensive multifactorial therapy and conventional multifactorial therapy groups). After those therapy for one year, a 10 years of follow up study will be performed. During this period, we take them together intensive education, and take conventional multifactorial therapy for both of two groups.
- At the beginning (0 year),the end of intensive multifactorial therapy (1 year), 5 years and 10 years, we will measure the endothelium-dependent arterial dilation, endothelium related cytokines such as ET-1, vWF,as well as blood glucose, HbA1c for all of individuals.
- We will compare the endothelial function,endothelium related cytokines such as ET-1, vWF,as well as blood glucose, HbA1c between intensive therapy group and conventional therapy group at different time points.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed type 2 diabetes,
- •Age: 40 >= age <=70 year old,
排除标准
- •Type 1 diabetes,
- •Mitochondrial diabetes
- •Patients with clinical detectable angiopathy,
- •Body Mass Index (BMI) > 30 Kg/m2,
- •Age < 40, or > 70 years old,
- •Malignant neoplasms, renal or liver diseases,
- •Known diabetes
研究组 & 干预措施
Intensive multifactorial group
Intensive multifactorial therapy group receive intensive blood glucose, blood pressure and blood lipids control.
干预措施: Intensive multifactorial group (Drug)
conventional multifactorial therapy group
Conventional multifactorial therapy group receive conventional blood glucose, blood lipids and blood lipids control to the local targets.
干预措施: conventional multifactorial therapy group (Drug)
结局指标
主要结局
The metabolic memory effect of endothelium-dependent arterial dilation
时间窗: 10 years
Before and after intensive multifactorial therapy (one year intensive therapy, HbAic, fasting blood glucose and postprandial 2 hour glucose reach to the targets),endothelial function is measured. The intensive and conventional groups are taken together, and give the same therapy during the follow up of 10 years. The endothelium-dependent arterial dilation is measured during follow up. The aim is that the improvement of endothelial function induced by intensive therapy will exist after 10 years.
次要结局
未报告次要终点
研究者
Xiang Guang-da
Director of Endocrinol Dept.
Wuhan General Hospital of Guangzhou Military Command