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

Yiming Mu

Status: Unknown

Conditions: Diabetic Kidney Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05047471

2021BY01

Details and patient eligibility

About

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).

Full 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;

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.