Diabetic Nephropathy (DN)
Conditions
Interventions
Gold Standard:Pathological examination based on renal biopsy
Index test:Urinary Extracellular Vesicle Testing
Sponsors
Jiangsu Provincial Government Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) **Age 18-75 years.** 2) **Meeting WHO 2023 diagnostic criteria for diabetes:** - Fasting plasma glucose >= 7.0 mmol/L, **or** - 2-hour postprandial glucose >= 11.1 mmol/L, **or** - HbA1c >= 6.5%. 3) **Diagnosed with diabetic kidney disease (DKD), defined as:** - Persistent proteinuria (urinary albumin-to-creatinine ratio [UACR] >= 30 mg/g), **or** - Estimated glomerular filtration rate (eGFR) = 10 years.** 5) **Voluntarily signed informed consent, with ability to understand and comply with study procedures.** 6) **Stable blood pressure control (systolic = 90 g/L, platelets >= 100×10?/L. - **Liver function:** ALT/AST <= 2.5× upper limit of normal (ULN). - **Serum potassium:** 3.5-5.5 mmol/L.
Exclusion criteria
Exclusion criteria: 1) **Non-diabetic kidney disease** (e.g., glomerulonephritis, polycystic kidney disease). 2) **Severe cardiovascular comorbidities** (e.g., recent myocardial infarction, unstable angina). 3) **Participation in other clinical trials within the past 6 months.** 4) **Active severe infections or liver disease** (e.g., active hepatitis B or C). 5) **Pregnant or lactating women.** 6) **Laboratory abnormalities:** - eGFR 5.5 mmol/L. 7) **Other conditions deemed ineligible by investigators** (e.g., poor compliance, life expectancy < 6 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary Extracellular Vesicle;Accuracy;Sensitivity;Specificity; | — |
Countries
China
Contacts
Public ContactShuang Qu
Jiangsu Provincial Government Hospital
Outcome results
None listed