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临床试验/NCT03692884
NCT03692884招募中不适用

Chongqing Diabetes and Its Chronic Complications Registry Study

Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
1
主要终点
The number of patients whoes Diabetic Kidney disease (DKD) is worsen

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of diabetes mellitus(based on the 1999 WHO diagnostic cretirial);
  • Age younger than 75 years old, gender is not limited;
  • Voluntary to sign on the informed consent.

排除标准

  • pregnant or breast-feeding women;
  • Patients with chronic disease requiring long-term glucocorticoid therapy;
  • Patients with severe infection (except for diabetic foot) or immune dysfunction.

结局指标

主要结局

The number of patients whoes Diabetic Kidney disease (DKD) is worsen

时间窗: 5 years

Worsen DKD is defined as Urine Albumin Creatinine Ratio (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.

次要结局

  • The number of patients who develop Diabetic Retinopathy(5 years)
  • The number of patients who develop Cardiovascular events(10 years)
  • The number of patients who develop DKD(5 years)
  • The number of patients whoes DR is worsen(5 years)
  • The number of patients who develop Diabetic foot(10 years)
  • The number of patients who develop Diabetic Neuropathy(5 years)

研究者

发起方
Chongqing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qifu Li

Director of endocrinology

Chongqing Medical University

研究点 (1)

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