Type 2 Diabetes Mellitus, Type 2 Diabetic Kidney Disease
Conditions
Interventions
Observation group:None
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients meeting the diabetes diagnostic criteria in the "Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 Edition)" with typical diabetes symptoms can be diagnosed with diabetes if they meet any one of the following four criteria: (1) Random blood glucose >= 11.1 mmol/L; (2) Fasting blood glucose >= 7.0 mmol/L; (3) OGTT 2-hour blood glucose >= 11.1 mmol/L; (4) HbA1c >= 6.5%. For those without typical diabetes symptoms, a diagnosis requires two blood glucose indicators at the same time point or two indicators at different time points reaching or exceeding the diagnostic cut-off (excluding random blood glucose). 2. Patients meeting the diagnostic criteria for diabetic kidney disease in the "Chinese Guidelines for the Prevention and Treatment of Diabetic Kidney Disease (2021 Edition)" can be diagnosed with DKD if diabetes is clearly the cause of kidney damage and other causes of CKD are excluded, and at least one of the following is present: (1) After excluding interfering factors, at least 2 out of 3 tests over 3-6 months show UACR >= 30 mg/g or UAER >= 30 mg/24 h (>= 20 µg/min); (2) eGFR < 60 ml·min^-1·(1.73 m^2)^-1 for more than 3 months; (3) Kidney biopsy shows pathological changes consistent with DKD. 3. 30 mg/g <= UACR <= 3000 mg/g; 4. 60 ml/min/1.73 m^2 <= eGFR <= 90 ml/min/1.73 m^2; 5. Not using ACEi/ARB, or using ACEi/ARB at a stable dose for 4 weeks or more (dose unchanged); 6. Voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Received treatment with other types of SGLT2 inhibitors or GLP-1 receptor agonists within the past three months. 2.Symptomatic genitourinary tract infection. 3.Patients with severe hepatic insufficiency (ALT or AST = 3 × ULN) or cardiac dysfunction (NYHA class IV). 4.Patients with ketoacidosis events within the past 3 months. 5.UACR>3000mg/g; 6.Subjects who are unable to cooperate with and complete the entire intervention and observation period due to various reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UACR Urine albumin-to-creatinine ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Countries
China
Contacts
Public ContactHong Chen
Zhujiang Hospital of Southern Medical University
Outcome results
None listed