To Improve the Ability of Early Screening and Diagnosis in Patients With Diabetic Nephropathy

NCT ID: NCT05047471

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-25
• Study Completion Date: 2023-06-30

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;

Conditions

Diabetic Kidney Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yiming Mu

OTHER

Sponsor Role: lead

Responsible Party

Yiming Mu

Director of department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yimin Mu, MD

Role: PRINCIPAL_INVESTIGATOR

The First Medical Center of Chinese PLA General Hospital

Locations

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

The 7th Medical Center of Chinese PLA General Hospital

Beijing, , China

The 8th Medical Center of Chinese PLA General Hospital

Beijing, , China

The First Medical Center of Chinese PLA General Hospital

Beijing, , China

Guangdong Provincial People's Hospital

Guangzhou, , China

Guangzhou First People's Hospital

Guangzhou, , China

Guangzhou Red Cross Hospital

Guangzhou, , China

Nanfang Hospital, Southern Medical University

Guangzhou, , China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, , China

Guiyang First People's Hospital

Guiyang, , China

Guiyang Second People's Hospital

Guiyang, , China

The Affiliated Hospital of Guizhou Medical University

Guiyang, , China

The Second Affiliated Hospital of Guizhou Medical University

Guiyang, , China

The First Affiliated Hospital of Anhui Medical University

Hefei, , China

NanjingNanjing Drum Tower Hospital( the Affiliated Hospital of Nanjing University Medical School)

Nanjin, , China

Nanjing First Hospital

Nanjing, , China

Nantong First People's Hospital

Nantong, , China

Qingdao Eighth People's Hospital

Qingdao, , China

Qingdao Third People's Hospital

Qingdao, , China

The Affiliated Hospital of Qingdao University

Qingdao, , China

People's Hospital of Rizhao

Rizhao, , China

Qingpu Branch of Zhongshan Hospital affiliated to Fudan University

Shanghai, , China

Shanghai Minhang District Central Hospital

Shanghai, , China

Shanghai Xuhui District Central Hospital

Shanghai, , China

Wusong Hospital, Zhongshan Hospital affiliated to Fudan University

Shanghai, , China

Zhongshan Hospital affiliated to Fudan University

Shanghai, , China

Second Affiliated Hospital of Soochow University

Suzhou, , China

The First Affiliated Hospital of Soochow University

Suzhou, , China

Taizhou Second People's Hospita

Taizhou, , China

Weihai Municipal Hospital

Weihai, , China

Renmin Hospital of Wuhan University

Wuhan, , China

The Central Hospital of Wuhan

Wuhan, , China

Tongji Hospital, Tongji Medical College Of HUST

Wuhan, , China

Wuhan No. 1 Hospital

Wuhan, , China

Wuhan No. 3 Hospital

Wuhan, , China

Wuhan No. 4 Hospital

Wuhan, , China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, , China

Yixing People's Hospital

Yixing, , China

Zhenjiang First People's Hospital

Zhenjiang, , China

The Affiliated Hospital of Zunyi Medical University

Zunyi, , China

Zunyi First People's Hospital

Zunyi, , China

Countries

China

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Related Links

http://med.wanfangdata.com.cn/Paper/Detail?dbid=WF_QK&id=PeriodicalPaper_zhtnb202104005

Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition)

Other Identifiers

2021BY01

Identifier Type: -

Identifier Source: org_study_id