Effects of Multifactorial Intervention on Type 2 Diabetes - A Multicenter, Open-Label, Randomized, Parallel Controlled, Community Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 6,300
- 试验地点
- 1
- 主要终点
- Integrated management rate of multiple risk factor in type 2 diabetes
研究概览
简要总结
The prevalence of diabetes mellitus has been increasing in recent decades in China, and vascular complication is the major burden in patients with type 2 diabetes. Previous studies demonstrated that only glycemic control was not effective enough to prevent or improve diabetic vascular complications, but guidelines from the Chinese Diabetes Society and other national guidelines recommend an integrated multifactorial treatment approach. In this study, we aim to evaluate the effect on diabetic vascular complications of a multifactorial intervention comprising behavior modification, polypharmacological therapy and periodical monitoring in patients with type 2 diabetes.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35-75 years old;
- •diagnosed as type 2 diabetes according to the criteria of the World Health Organization in 1999.
排除标准
- •type 1 diabetes，specific types of diabetes，gestational diabetes or pregestational diabetes;
- •acute cardiovascular or cerebrovascular accidents within past 3 months;
- •severe hepatic or renal dysfunction;
- •malignant tumor;
- •allergic history or contraindication for any drugs in trials;
- •taking part in other clinical trials;
- •obviously poor compliance.
研究组 & 干预措施
Integrated Treatment
干预措施: Lifestyle therapy (Behavioral)
Integrated Treatment
干预措施: Pharmacotherapy (Drug)
Integrated Treatment
干预措施: Monitoring and management (Other)
General Treatment
干预措施: General treatment (Other)
结局指标
主要结局
Integrated management rate of multiple risk factor in type 2 diabetes
时间窗: 30 months
Multiple risk factor: plasma glucose, blood pressure, serum lipid profiles and obesity
Incidence of diabetic vascular complications
时间窗: 30 months
Diabetic vascular complications: both macrovascular and microvascular complications
Control rate of diabetes and diabetic vascular complications
时间窗: 30 months
次要结局
- Carotid intima-media thickness (IMT)(30 months)
- Ankle brachial index (ABI)(30 months)
- Urine albumin creatinine ratio (UACR)(30 months)
- Estimated glomerular filtration rate (eGFR)(30 months)
- Stage of diabetic retinopathy evaluated by fundus photograph(30 months)
研究者
Jia-jun Zhao
Professor
Shandong Provincial Hospital