Diagnostic Performance of Urinary Clusterin for Early Detection of Diabetic Kidney Disease in Pediatric Type 1 Diabetes Mellitus: A Case-Control Analysis.

Abstract

Background: Urinary Clusterin, a glycoprotein linked to oxidative stress and tubular injury, is being evaluated as a more sensitive biomarker for diabetic kidney disease (DKD). This study aims to assess the role of Clusterin in the early detection and prognostication of diabetic kidney disease in children with Type 1 Diabetes Mellitus (T1DM), addressing a critical gap in pediatric clinical data.

Methods: This case-control study at Beni-Suef University compared 50 children with T1DM (duration ≥5 years) to 40 healthy controls. Assessments included Body Mass Index (BMI), glycated hemoglobin (HbA1c), and lipid profiles. Urinary Clusterin was measured using Enzyme Linked Immunosorbent Assay (ELISA). A Receiver Operating Characteristic (ROC) curve analysis was employed to determine the diagnostic performance of urinary Clusterin in detecting diabetic nephropathy.

Results: Diabetic cases exhibited significantly higher levels of AST, cholesterol, triglycerides, and serum creatinine compared to the control group. The urinary profile revealed significantly elevated urinary creatinine, albumin, and albumin-to-creatinine ratios in cases, with urinary clusterin levels being significantly higher in children with diabetes (49.7 vs. 32.3 pg/mL, p<0.001) than in healthy controls. Within the case group, urinary clusterin significantly correlated with ALT, serum creatinine, and triglycerides, although no significant associations were found with age, BMI, or HbA1c. At a cutoff value of 37.6 pg/mL, urinary clusterin is a highly effective marker for early detection of diabetic nephropathy with an 80% sensitivity, and 90% specificity.

Conclusion: Urinary clusterin is a potential non-invasive biomarker for early diabetic nephropathy in children with T1DM, outperforming traditional measures and offering a promising tool for earlier screening and improved clinical management.