A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China (CCMR-3B Ext)
A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China - 3B Extension A Study of China Cardiometabolic Registries (CCMR)
研究概览
地位
条件
详细说明
Limited by its cross sectional design, 3B study was not be able to provide any information on how various patterns of treatment and prescribing behaviors would impact the outcomes of prevention of cardiovascular and cardio-renal diseases in type 2 diabetes longitudinally. This information, however, would be crucial in better guiding the real world medical practice and maximizing the effectiveness of medical treatment for better controlling cardiovascular risk factors.
The 3B Extension study is thus designed to extend the 3B study by continuing to follow up on enrolled patients for 3 years. The 3B Extension study is expected to demonstrate the clinical outcomes of nationally representative type 2 diabetes patients who are treated by endocrinologists, cardiologists and nephrologists separately in all tiers of hospitals, as measured by diabetes progression, incidence of cardiovascular complications, and incidence of microvascular complications. It will be the first study of this scale in China based on its exclusivity, extensiveness, and the level of government and national thought leaders' support. It will be conducted in collaboration with the advisory board of China Cardiometabolic Registries (CCMR).
研究类型
注册 (预期的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age 40 years or older
- Outpatients who meet the inclusion and exclusion criteria of 3B study
- With hypertension,dyslipidemia and one of the following:
- History of acute coronary artery disease or ischemic stroke
- Age > 65 years old
- Overweight or obesity (BMI > 24 kg/m2)
- Microalbuminuria or albuminuria
- Current smoker
Exclusion Criteria:
- Patients with type 1 DM
- Pregnant or breast feeding women
- Patients who are unable to or not willing to return for follow up visits every 6 months for 3 years;
- Patients have severe heart failure (NYHA Class III-IV)
- Patients with severe renal deficiency (creatinine clearance < 30 ml/min)
- Patients who are not willing to sing the informed consent form;
- Patients who are participating in any other interventional clinical studies,
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
with CAD
Patients with hypertension and dyslipidemia with prior CAD
|
|
without CAD
Patients with hypertension and dyslipidemia without prior CAD
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of CVD events
大体时间：3 years
|
The CVD event is defined as composite of :
|
3 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Annual incidence of microvascular complications
大体时间：3 years
|
3 years
|
合作者和调查者
合作者
调查人员
- 首席研究员：Linong Ji, MD、People's Hospital, Beijing University
- 首席研究员：Dayi Hu, MD、People's Hospital, Beijing University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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