Role of Novel Biomarkers Urinary NGAL and MCP-1 in Predicting Progression of Diabetic Kidney Disease in Type 2 DM

DKD prevalence rate is continuously rising globally and is the leading cause of end-stage renal disease, with a high mortality rate. Limited predictive value of Albuminuria and increased prevalence of heterogeneity of DKD emphasizes the need for novel biomarkers in predicting progression. Urinary NGAL & MCP-I are upcoming promising biomarkers in tubular injury and inflammation in predicting the progression and are non-invasive and easy to execute in the laboratory. This study evaluates biomarkers from three key pathogenic pathways of DKD progression to predict its prognostic value. This is a single-center Prospective Cohort study. Patients diagnosed with DKD visiting the department of nephrology and medicine OPD will be recruited for the study. Baseline demographic, clinical and laboratory data will be collected. Urine samples will be collected at the time of enrollment for NGAL and MCP-1 analysis.

Patients will be followed up every 3 months for 1 year prospectively for the DKD progression from the date of enrolment. Urine albumin and serum creatinine value will be calculated  during each follow-up.  eGFR will be calculated using serum creatinine values and CKD-EPI equation. The primary outcome measure will be rapid progressors (> 5ml/min /1.73m2 /year) and non-rapid progressors (< 5ml/min /1.73m2 /year) based on eGFR, and secondary outcome measure will be the worsening of proteinuria/new onset of  microalbuminuria/macroalbuminuria. Analysis of risk factors in rapid progressors including NGAL and MCP-1 will be done.  ROC analysis for NGAL and MCP-1 will be performed for optimum cutoff.