Diabetic Kidney Disease
Conditions
Interventions
Healthy Control Group:None
Sponsors
Shenzhen University General Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diabetic Kidney Disease (DKD) Group (1) Diagnostic criteria: 1) Meet the 2023 ADA diagnostic criteria for diabetic kidney disease; 2) UACR 30–300 mg/g (microalbuminuria stage); 3) eGFR >=60 mL/min/1.73 m^2 (CKD stages 1–2); (2) Medical history requirements: 1) Type 2 diabetes duration >=5 years; 2) Stable glycemic control in the past 3 months (HbA1c 6.5–9.0%); (3) Treatment status: 1) SGLT2 inhibitors/RAAS blockers are allowed, provided the dose has been stable for >=1 month; (4) Demographic characteristics: 1) Age 40–75 years; 2) Any sex (sex ratio must be recorded); 2. Healthy Control Group (1) Metabolic parameters: 1) Fasting blood glucose =90 mL/min/1.73 m^2; (2) Exclusion of diseases: 1) No history of diabetes, hypertension, chronic kidney disease, or other metabolic diseases; (3) Medication history: 1) No use of nephrotoxic drugs (e.g., NSAIDs) in the past 6 months; (4) Matching requirements: 1) Age matched to the DKD group within +/-5 years; 2) Sex ratio balanced with the DKD group; (Note: All participants must sign an informed consent form and commit to specimen collection and follow-up.)
Exclusion criteria
Exclusion criteria: 1. Exclusion Criteria for All Subjects (General) (1) Complicated with severe systemic diseases: 1) Malignant tumors, active infections (such as HIV, HBV, active tuberculosis); 2) Severe cardiovascular and cerebrovascular diseases (NYHA functional class III–IV, history of myocardial infarction or stroke within 6 months); (2) Kidney-related exclusions: 1) Non-diabetic kidney disease (such as glomerulonephritis, polycystic kidney disease, etc.); 2) Acute kidney injury (AKI) within 3 months; (3) Special physiological conditions: 1) Pregnant or lactating women; 2) Recent (within 1 month) participation in other interventional clinical trials; (4) Other exclusion factors: 1) Mental illness or cognitive impairment that prevents cooperation with the study; 2) Alcohol abuse (men >40 g/day, women >20 g/day) or history of drug abuse. 2. Additional Exclusion Criteria for the DKD Group (1) Manifestations of disease progression: 1) Macroalbuminuria (UACR >300 mg/g) or eGFR =10 mg/day). 3. Additional Exclusion Criteria for the Healthy Control Group (1) Metabolic abnormalities: 1) Fasting blood glucose >=6.1 mmol/L or OGTT 2-hour blood glucose >=7.8 mmol/L; 2) Blood pressure >=140/90 mmHg (without medication). (Note: All exclusion criteria must be confirmed through medical record review and laboratory tests before enrollment.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in TGF-ß2 expression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic performance of combined metabolic biomarkers;Correlation between TGF-ß2 and UACR, eGFR;Complications related to sample collection; | — |
Countries
China
Contacts
Public ContactWang Yu
Shenzhen University General Hospital
Outcome results
None listed