Abstract:
Diabetic kidney disease is a major complication of type 2 diabetes mellitus and a
leading cause of chronic kidney disease (CKD) and end-stage renal failure. Early detection of renal
damage remains a clinical challenge, as traditional biomarkers such as serum creatinine and
microalbuminuria have limited sensitivity in the initial stages of the disease.
The aim of this study was to investigate the role of nephrin as an early marker of structural
damage to the glomerular apparatus in patients with CKD stages 1–2 associated with type 2 diabetes
mellitus.
A total of 88 patients were included and divided into two groups: CKD stage 1 (n = 53) and
CKD stage 2 (n = 35). All patients underwent comprehensive clinical and laboratory evaluation,
including biochemical parameters, metabolic indicators, and hemostatic system assessment. Nephrin
levels were determined using a sandwich enzyme-linked immunosorbent assay (ELISA).
Patients with CKD stage 2 were significantly older and had a longer disease duration. While
creatinine levels showed only moderate increases, nephrin concentrations were more than twofold
higher in CKD stage 2 compared to stage 1 (p < 0.001) and significantly exceeded control values.
ROC analysis demonstrated excellent diagnostic performance of nephrin (AUC = 0.91; 95% CI:
0.84–0.97; p < 0.001), with an optimal cut-off value of ≥8.5 ng/mL providing 86% sensitivity and
83% specificity.
These findings indicate that nephrin is a highly sensitive and specific biomarker capable of
detecting early podocyte injury and structural renal changes prior to significant decline in renal
function. Its incorporation into clinical practice may improve early diagnosis and enable timely
nephroprotective interventions in patients with type 2 diabetes mellitus
