Chongqing Diabetes Registry

赞助:

合作者:

信息的提供 (责任方):

Qifu Li，First Affiliated Hospital of Chongqing Medical University

追踪信息

首次提交日期 ^ICMJE

July 17, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

July 1, 2018

预计主要完成日期

July 1, 2023 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

The number of patients who develop Diabetic Kidney disease (DKD)[ Time Frame: 5 years ]

Diabetic Kidney Disease is defined as Urine Albumin Creatinine Ratio （UACR） > 30 mg/g Cr（twice out of three measures），or estimated Glomerular Filtration Rate（eGFR）＜60ml/min/1.73m2.

The number of patients whoes DKD is worsen[ Time Frame: 5 years ]

Worsen DKD is defined as UACR > 300 mg/g Cr（twice out of three measures）, or 24 hours urinary protein> 300 mg / 24 h, or double serum creatinine level and at least 200μmol/l (2.26 mg/dl), or require renal replacement therapy, or death due to kidney disease.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

The number of patients who develop Diabetic Retinopathy[ Time Frame: 5 years ]
New Diabetic Retinopathy
The number of patients whoes DR is worsen[ Time Frame: 5 years ]
Worsen DKD is defined as any eye with original Diabetic Rretinopathy aggravated by at least one level, or progress to proliferation retinopathy, or appearance of macular degeneration, or at least one eye with blindness (refer to the WHO standards, the Snellen-chart vision drop to 6/60 or less), or to accept retinal photocoagulation treatment, or accept vitrectomy.
The number of patients who develop Diabetic Neuropathy[ Time Frame: 5 years ]
Diabetic Peripheral Neuropathy is defined as Neuropathy Symptom Score/Neuropathy Disability Score（NSS/NDS） with at least two positive outcomes, or electromyography examination to identify nerve damage；Diabetic Autonomic Neuropathy is defined as tachycardia at rest (Heart Ratio>100bpm) and postural hypotension (standing position leads systolic blood pressure reduction >20mmHg).
The number of patients who develop Cardiovascular events[ Time Frame: 10 years ]
Cardiovascular events are difined as death of cardiovascular events, or non-fatal myocardial infarction, or non-fatal stroke, or revascularization procedure (cardiac, carotid, or peripheral), or hospitalization for heart failure.
The number of patients who develop Diabetic foots[ Time Frame: 10 years ]

描述性信息

简略标题 ^ICMJE

Chongqing Diabetes Registry

正式标题 ^ICMJE

Chongqing Diabetes Registry

简要概况

To investigate the risk factors and biomarkers of the microvascular disease，macrovascular disease and neuropathy in patients with diabetes.

详细说明

This study is a prospective cohort study. About 5000 patients with diabetes from the Chongqing Diabetes Centre,Chongqing,China, will be enrolled for long-term follow-up.Information on socio-demographic parameters, medical history, current drug use,lifestyle factors, anthropometric measurements, metabolic control indicators and diabetes complications examination will be documented. Blood and urine samples will be collected. This study aimed to assess risk factors and biomarkers of occurrence and development of diabetic microvascular disease,macrovascular disease and neuropathy in patients with diabetes.

研究类型 ^ICMJE

Observational [Patient Registry]

研究阶段

研究设计 ^ICMJE

分配:
干预模型:
干预模型描述:
盲法: Observational [Patient Registry]
盲法描述:
主要目的:

适用条件 ^ICMJE

干预项目 ^ICMJE

研究工具

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

5000

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

July 1, 2030

预计主要完成日期

July 1, 2023 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. Diagnosis of diabetes mellitus（based on the 1999 WHO diagnostic cretirial）; 2. Age younger than 75 years old, gender is not limited; 3. Voluntary to sign on the informed consent. Exclusion Criteria: 1. pregnant or breast-feeding women; 2. Patients with chronic disease requiring long-term glucocorticoid therapy; 3. Patients with severe infection (except for diabetic foot) or immune dysfunction.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：75 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

China

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Qifu Li，First Affiliated Hospital of Chongqing Medical University

研究赞助商 ^ICMJE

Chongqing Medical University

合作者 ^ICMJE

研究员 ^ICMJE

Study Chair: Qifu Li, phD First Affiliated Hospital of Chongqing Medical University

PRS 账户

First Affiliated Hospital of Chongqing Medical University

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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