To Improve the Ability of Early Screening and Diagnosis in Patients With Diabetic Nephropathy
- Conditions
- Diabetic Kidney Disease
- Registration Number
- NCT05047471
- Lead Sponsor
- Yiming Mu
- Brief Summary
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).
- Detailed Description
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:
1. To understand the epidemiological disease burden of DKD in China, and to investigate the prevalence rate, awareness rate and screening rate of DKD;
2. To understand the treatment status of patients with DKD in China;
3. To provide real-world data on the efficacy and safety of SGLT2i in the treatment of DKD in China;
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10000
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Screening rate 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 at the time of screening Assess whether taking different categories of medications is a risk factor for albuminuria
Prevalence of DKD at the time of screening Prevalence of DKD (UACR \> 30 mg/g); The prevalence of microalbuminuria (30 mg/g β€ UACR β€ 300 mg/g); The prevalence of massive proteinuria (UACR \> 300 mg/g).
Prescription proportion of various anti-diabetic drugs for patients with DKD 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 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 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 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 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) at baseline It is defined as more than 3.37mmol/L, "elevated" and "normal" for evaluation
Awareness rate 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 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 at baseline Baseline glycosylated hemoglobin is divided into quartiles for evaluation
risk factors of albuminuria: Drinking 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
- Secondary Outcome Measures
Name Time Method OR of the incidence of the adverse events at 6 months the odds ratio of the incidence of the adverse events of interest during the 6-month observation period between SGLT2i and non-SGLT2i group
MD of the change of UACR at 6 months the mean difference of the change of UACR from baseline between SGLT2i and non-SGLT2i group
Trial Locations
- Locations (50)
The 7th Medical Center of Chinese PLA General Hospital
π¨π³Beijing, China
Guangzhou Red Cross Hospital
π¨π³Guangzhou, China
Guiyang Second People's Hospital
π¨π³Guiyang, China
The Second Affiliated Hospital of Guizhou Medical University
π¨π³Guiyang, China
The First Affiliated Hospital of Anhui Medical University
π¨π³Hefei, China
Qingdao Eighth People's Hospital
π¨π³Qingdao, China
Shanghai Minhang District Central Hospital
π¨π³Shanghai, China
Wuhan No. 3 Hospital
π¨π³Wuhan, China
Yixing People's Hospital
π¨π³Yixing, China
The Affiliated Hospital of Xuzhou Medical University
π¨π³Xuzhou, China
Zhenjiang First People's Hospital
π¨π³Zhenjiang, China
The Affiliated Hospital of Zunyi Medical University
π¨π³Zunyi, China
Airport Area of Peking University Third Hospital
π¨π³Beijing, China
Beijing Haidian Hospital
π¨π³Beijing, China
Beijing Luhe Hospital, Capital Medical University
π¨π³Beijing, China
Peking University Third Hospital Yanqing Hospital
π¨π³Beijing, China
Peking University Third Hospital
π¨π³Beijing, China
Strategic Support Force Specialty Medical Center
π¨π³Beijing, China
The 3th Medical Center of Chinese PLA General Hospital
π¨π³Beijing, China
The 4th Medical Center of Chinese PLA General Hospital
π¨π³Beijing, China
The 5th Medical Center of Chinese PLA General Hospital
π¨π³Beijing, China
The 6th Medical Center of Chinese PLA General Hospital
π¨π³Beijing, China
The 8th Medical Center of Chinese PLA General Hospital
π¨π³Beijing, China
The First Medical Center of Chinese PLA General Hospital
π¨π³Beijing, China
Guangdong Provincial People's Hospital
π¨π³Guangzhou, China
Guangzhou First People's Hospital
π¨π³Guangzhou, China
Nanfang Hospital, Southern Medical University
π¨π³Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
π¨π³Guangzhou, China
NanjingNanjing Drum Tower Hospital( the Affiliated Hospital of Nanjing University Medical School)
π¨π³Nanjin, China
Guiyang First People's Hospital
π¨π³Guiyang, China
The Affiliated Hospital of Guizhou Medical University
π¨π³Guiyang, China
Nantong First People's Hospital
π¨π³Nantong, China
Qingdao Third People's Hospital
π¨π³Qingdao, China
The Affiliated Hospital of Qingdao University
π¨π³Qingdao, China
People's Hospital of Rizhao
π¨π³Rizhao, China
Qingpu Branch of Zhongshan Hospital affiliated to Fudan University
π¨π³Shanghai, China
Shanghai Xuhui District Central Hospital
π¨π³Shanghai, China
Wusong Hospital, Zhongshan Hospital affiliated to Fudan University
π¨π³Shanghai, China
Zhongshan Hospital affiliated to Fudan University
π¨π³Shanghai, China
Second Affiliated Hospital of Soochow University
π¨π³Suzhou, China
The First Affiliated Hospital of Soochow University
π¨π³Suzhou, China
Taizhou Second People's Hospita
π¨π³Taizhou, China
Weihai Municipal Hospital
π¨π³Weihai, China
Renmin Hospital of Wuhan University
π¨π³Wuhan, China
The Central Hospital of Wuhan
π¨π³Wuhan, China
Tongji Hospital, Tongji Medical College Of HUST
π¨π³Wuhan, China
Wuhan No. 1 Hospital
π¨π³Wuhan, China
Wuhan No. 4 Hospital
π¨π³Wuhan, China
Zunyi First People's Hospital
π¨π³Zunyi, China
Nanjing First Hospital
π¨π³Nanjing, China