Diabetes, Diabetic Kidney Disease
Conditions
Interventions
Gold Standard:Glomerular filtration rate (GFR) less than 60 ml/min/1.73m^2 or urine albumin/creatinine ratio (ACR) more than 30 mg/g for more than 3 months.
Index test:Dematin Actin Binding Protein
Sponsors
Luhe Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18; 2. 18.5= 6.5, fasting blood glucose >= 7.0 mmol/L, 2 hours postprandial glucose >= 11.1 mmol/L; or receiving oral antidiabetic medication and/or pancreatic islets without any prior adjustment to the medication regimen for 4 weeks or more). 4. Type 2 diabetes was diagnosed according to the diagnostic criteria provided in the Chinese Guidelines for the Prevention and Control of Type 2 Diabetes Mellitus (2020 Edition), and DKD was diagnosed according to the diagnostic criteria for DKD provided in the Clinical Practice Guidelines for the Management of Diabetes Mellitus in Chronic Kidney Disease (KDIGO 2022).
Exclusion criteria
Exclusion criteria: 1. Diagnostic record of type 1 diabetes mellitus, polycystic kidney disease, nephrotic syndrome, interstitial nephritis, lupus nephritis, or antineutrophil cytoplasmic antibody-associated vasculitis; 2. Cytotoxic or immunosuppressive therapy (glucocorticoids (e.g., prednisone), cyclophosphamide, cyclosporine, azathioprine, methotrexate) for primary or secondary nephropathy within 6 months prior to enrollment, history of organ (including kidney) transplantation; 3. Subjects who have been treated with SGLT2i within 8 weeks prior to enrollment, any renin inhibitor (ACEI, ARB), GLP-1, fenetylline, and who cannot be discontinued during the break-in period or during the treatment period; 4. Urinary tract infection (WBC), hematuria, chronic cardiac failure, menstrual or high blood pressure (>=180/110 mmHg), ketoacidosis; 5. Those who did not agree to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal function (blood creatinine, urea nitrogen, urine protein/creatinine ratio);Dematin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Model evaluation indicators: negative predictive value, positive predictive value, area under the curve; | — |
Countries
China
Contacts
Public ContactCao Haodi
Luhe Hospital, Capital Medical University
Outcome results
None listed