Healthy China - The Improvement Projects for the Screening Ability of Diabetes and Its Complications And for the Standardized Ability of Diagnosis and Treatment for Patients With Early Diabetic Nephropathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 试验地点
- 50
- 主要终点
- Screening rate
研究概览
简要总结
This is a large-scale, multi-center, observational study. It is planned to establish a large database of 10,000 patients with type 2 diabetes mellitus to investigate the prevalence, awareness and screening rates of diabetes kidney disease (DKD), and provide real-world data on the efficacy and safety of sodium glucose cotransporter 2 inhibitors (SGLT2i) in patients with type 2 diabetes mellitus (T2DM).
详细描述
Among the various complications of diabetes mellitus, DKD is considered as a major threat and is one of the manifestations of diabetic microangiopathy. it is one of the main causes of death for patients with T2DM.
Albuminuria is the earliest manifestation of DKD, which is mostly asymptomatic at the early stage, if the albuminuria is poorly controlled, it may develop into clinical DKD. Therefore, it is very important to improve the patients' awareness of DKD, regularly screen early kidney diseases and use drugs rationally.
In order to promote the standardization of diagnosis and treatment of patients with DKD, improve the knowledge and screening rate of patients with DKD, help the formation of health literacy, healthy behavior and lifestyle, the investigators planned the study.
STUDY OBJECTIVES:
- To understand the epidemiological disease burden of DKD in China, and to investigate the prevalence rate, awareness rate and screening rate of DKD;
- To understand the treatment status of patients with DKD in China;
- To provide real-world data on the efficacy and safety of SGLT2i in the treatment of DKD in China;
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •It is known that patients with T2DM has a history of more than 12 months (the WHO1999 Standard) and is treated with at least one anti-diabetic agent.
- •Gender and age: men and women who are at least 18 years old with informed consent.
- •Patients are willing and able to provide written informed consent before participating in this study.
排除标准
- •Type 1 diabetes mellitus (DM)
- •Patients with severe ketosis, diabetic coma, severe infection or severe trauma
- •Perioperative patients
- •Patients with severe renal impairment and advanced nephropathy (eGFR < 45 ml/min/1.73m2)
- •Renal transplant patients
- •Patients are participating in or have participated in any other clinical trials in the past 3 months
- •Any disease with a life expectancy of less than 2 years according to the clinical judgment of the investigator
- •Pregnant or lactating women
- •Patients judged by the investigator to be unsuitable for participating in the study.
结局指标
主要结局
Screening rate
时间窗: at the time of screening
Screening rate=(The number of people @who have checked urine protein within one year)/(The number of people involved in total diabetes)
risk factors of albuminuria: medication categories
时间窗: at the time of screening
Assess whether taking different categories of medications is a risk factor for albuminuria
Prevalence of DKD
时间窗: at the time of screening
Prevalence of DKD (UACR \> 30 mg/g); The prevalence of microalbuminuria (30 mg/g ≤ UACR ≤ 300 mg/g); The prevalence of massive proteinuria (UACR \> 300 mg/g).
Prescription proportion of various anti-diabetic drugs for patients with DKD
时间窗: at the time of screening
Prescription ratio of a certain hypoglycemic agent =(The number of people using a certain hypoglycemic agent)/(Total number of DKD)
risk factors of albuminuria: Current smoking
时间窗: at the time of screening
According to the "Current smoking" in the questionnaire collected during the screening to evaluate whether smoking is the risk of albuminuria
risk factors of albuminuria: gender
时间窗: at the time of screening
According to the "gender" in the questionnaire collected during the screening to evaluate whether gender is the risk of albuminuria
risk factors of albuminuria: Age
时间窗: at the time of screening
According to the "date of birth" in the questionnaire collected during the screening, the age of diabetic patients is divided into quartiles for evaluation
risk factors of albuminuria: Hypertension
时间窗: at baseline
It is defined as the adults' systolic blood pressure which is greater than or equal to 140mmHg and/or diastolic blood pressure which is greater than or equal to 90mmHg. "hypertension" and "non-hypertension" for evaluation
risk factors of albuminuria: Increase in Low density lipoprotein cholesterol (LDL-C)
时间窗: at baseline
It is defined as more than 3.37mmol/L, "elevated" and "normal" for evaluation
Awareness rate
时间窗: at the time of screening
Awareness rate=(The number of people who know their abnormal albuminuria)/(The number of people with diabetes mellitus complicated with albuminuria)
risk factors of albuminuria: Course of disease
时间窗: at the time of screening
It is defined as the years of diagnosis of diabetes. According to the "Date of Diagnosis" in the questionnaire collected during the screening, the course years of diabetes patients are divided into quartiles for evaluation
risk factors of albuminuria: Glycosylated hemoglobin
时间窗: at baseline
Baseline glycosylated hemoglobin is divided into quartiles for evaluation
risk factors of albuminuria: Drinking
时间窗: at the time of screening
According to the " Drinking " in the questionnaire collected during the screening to evaluate whether Drinking is the risk of albuminuria
次要结局
- OR of the incidence of the adverse events(at 6 months)
- MD of the change of UACR(at 6 months)
研究者
Yiming Mu
Director of department
Beijing Great Physician Commonweal Foundation