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;

Study Timeline

• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-11
• Study First Posted: 2021-09-17
• Study Start: 2021-12-25
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-27
• Primary Completion: 2023-05
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
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
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 ≤ UACR ≤ 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

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)

Airport Area of Peking University Third Hospital; 🇨🇳 Beijing, China

Beijing Haidian Hospital; 🇨🇳 Beijing, China

Beijing Luhe Hospital, Capital Medical University; 🇨🇳 Beijing, China

Peking University Third Hospital Yanqing Hospital; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, China

Strategic Support Force Specialty Medical Center; 🇨🇳 Beijing, China

The 3th Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, China

The 4th Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, China

The 5th Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, China

The 6th Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, China

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