Diagnostic Accuracy of Urinary KIM-1, NGAL, and NAG for Early Detection of Diabetic Kidney Disease in Type 2 Diabetes Mellitus Patients: A Central Indian Study
- Jun 16
- 2 min read
https://doi.org/10.66715/jsccr/2025.v2.i4.3744 | Original Research | 2025 | Volume-2 | Issue-4 | Page 37-44
Mr. Rahul Sharma, PhD Medical Biochemistry Research Scholar, Department of Biochemistry, Index Medical College Hospital and Research Centre, Malwanchal University, Indore
Dr. Shreya Nigoskar, Prof. & Head, Department of Biochemistry, Index Medical College
Hospital and Research Centre, Malwanchal University, Indore
Abstract
Background: Diabetic Kidney Disease (DKD) is one of the most common microvascular complications of Type 2 Diabetes Mellitus (T2DM) and a leading cause of chronic kidney disease and end-stage renal failure worldwide. Conventional markers such as serum creatinine and urinary albumin excretion often fail to detect renal injury at its earliest stages. Novel urinary biomarkers including Kidney Injury Molecule-1 (KIM-1), Neutrophil Gelatinase-Associated Lipocalin (NGAL), and N-Acetyl-β-D-Glucosaminidase (NAG) have emerged as promising indicators of early tubular damage and may facilitate earlier diagnosis of DKD.
Objective: To evaluate and compare the diagnostic accuracy of urinary KIM-1, NGAL, and NAG for the early detection of diabetic kidney disease among patients with Type 2 Diabetes Mellitus in a Central Indian population. Materials and Methods: This cross-sectional hospital-based study included T2DM patients categorized according to the presence and severity of diabetic kidney disease, along with healthy controls. Clinical characteristics, glycemic parameters, renal function tests, estimated glomerular filtration rate (eGFR), and urinary albumin-creatinine ratio (UACR) were assessed. Urinary KIM-1, NGAL, and NAG levels were measured using standardized ELISA and enzymatic methods. Diagnostic performance was evaluated using Receiver Operating Characteristic (ROC) curve analysis, and sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve (AUC) were calculated. Results: Urinary KIM-1, NGAL, and NAG levels were significantly elevated in T2DM patients with DKD compared to diabetic patients without nephropathy and healthy controls (p < 0.001). All three biomarkers demonstrated significant correlations with HbA1c, UACR, serum creatinine, and eGFR. ROC curve analysis revealed that urinary KIM-1 exhibited the highest diagnostic accuracy for identifying early DKD, followed by urinary NGAL and NAG. The combination of these biomarkers further improved diagnostic sensitivity and specificity compared with individual markers and conventional renal parameters. Conclusion: Urinary KIM-1, NGAL, and NAG are sensitive and reliable biomarkers for the early detection of diabetic kidney disease in T2DM patients. Among them, KIM-1 demonstrated superior diagnostic performance. Combined assessment of these urinary biomarkers may provide a valuable non-invasive strategy for identifying subclinical renal injury