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Background <p>Early detection of diabetic nephropathy (DN) is crucial for effective management in patients with type 2 diabetes mellitus (T2DM). Non-invasive biomarkers such as cystatin C and fibrinogen may help identify early renal changes. This study evaluated their clinical utility in detecting early glomerular filtration rate (GFR) alterations and DN among Saudi T2DM patients.</p> Methods <p>A case–control study was conducted involving 150 T2DM patients and 50 healthy controls from Al Madinah Al Munawarah, Saudi Arabia. Clinical data were collected using a structured questionnaire. Blood and urine samples were analyzed to measure plasma cystatin C, fibrinogen, and renal function markers.</p> Results <p>Plasma cystatin C and fibrinogen levels were significantly elevated in diabetic patients, particularly among those with macroalbuminuria, followed by microalbuminuria and normoalbuminuria (<i>P</i> &lt; 0.001). Both biomarkers demonstrated significant positive correlations with age, duration of diabetes, glucose, urea, albuminuria, and the albumin-to-creatinine ratio (ACR), as well as a negative correlation with GFR. Fibrinogen exhibited the highest sensitivity (75%) and specificity (100%) for early DN detection, including instances without albuminuria. When combined with cystatin C, the sensitivity was 73% and specificity was 98%.</p> Conclusion <p>Plasma cystatin C and fibrinogen levels may indicate a diabetic patient’s kidney condition as supplementary tubular factors. They serve as promising non-invasive biomarkers for the early detection of diabetic nephropathy in DM. Fibrinogen alone demonstrates the highest sensitivity and specificity. When combined with cystatin C, diagnostic accuracy remained high (AUC = 0.91), though sensitivity slightly decreased to 73%. These findings support their potential clinical application in early renal assessment and risk stratification among T2DM patients.</p>

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Endogenous Non-Invasive Early Biomarkers for Diabetic Nephropathy in Type 2 Diabetic Saudi Patients: A Case Control Study

  • 期刊论文

  • 发表日期：

    2025年7月22日

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  • Wedad Alruwaytie,
  • Amal Mohamad Husein Mackawy

摘要

Background

Early detection of diabetic nephropathy (DN) is crucial for effective management in patients with type 2 diabetes mellitus (T2DM). Non-invasive biomarkers such as cystatin C and fibrinogen may help identify early renal changes. This study evaluated their clinical utility in detecting early glomerular filtration rate (GFR) alterations and DN among Saudi T2DM patients.

Methods

A case–control study was conducted involving 150 T2DM patients and 50 healthy controls from Al Madinah Al Munawarah, Saudi Arabia. Clinical data were collected using a structured questionnaire. Blood and urine samples were analyzed to measure plasma cystatin C, fibrinogen, and renal function markers.

Results

Plasma cystatin C and fibrinogen levels were significantly elevated in diabetic patients, particularly among those with macroalbuminuria, followed by microalbuminuria and normoalbuminuria (P < 0.001). Both biomarkers demonstrated significant positive correlations with age, duration of diabetes, glucose, urea, albuminuria, and the albumin-to-creatinine ratio (ACR), as well as a negative correlation with GFR. Fibrinogen exhibited the highest sensitivity (75%) and specificity (100%) for early DN detection, including instances without albuminuria. When combined with cystatin C, the sensitivity was 73% and specificity was 98%.

Conclusion

Plasma cystatin C and fibrinogen levels may indicate a diabetic patient’s kidney condition as supplementary tubular factors. They serve as promising non-invasive biomarkers for the early detection of diabetic nephropathy in DM. Fibrinogen alone demonstrates the highest sensitivity and specificity. When combined with cystatin C, diagnostic accuracy remained high (AUC = 0.91), though sensitivity slightly decreased to 73%. These findings support their potential clinical application in early renal assessment and risk stratification among T2DM patients.