Abstract
BACKGROUND: Peripheral arterial disease (PAD) is a serious atherosclerotic cardiovascular disease frequently associated with prolonged type 2 diabetes mellitus (T2D). It is marked by arterial plaque formation that impairs blood flow to the limbs, leading to symptoms like claudication, ischemic rest pain, ulcers, and gangrene. Fatty acid binding protein 4 (FABP4) is a molecule that plays a crucial role in regulating lipid transport and metabolism. However, the role of Fatty Acid Binding Protein 4 in PAD remains poorly understood. Understanding the involvement of FABP4 in PAD could aid early diagnosis and therapeutic strategies. METHODOLOGY: This is a small, single-centre observational cross-sectional study. Trial was registered in CTRI (CTRI/2022/12/047992) and the date of registration is 12/12/2022. The study enrolled 90 individuals from West Bengal, India, categorized into healthy controls (n = 30), T2D patients (n = 30), and PAD patients (n = 30; all with T2D and ABI <0.9). Serum FABP4 levels were measured using ELISA, and physical (ABI, blood pressure, BMI) and biochemical (lipid profile, glucose levels) parameters were evaluated. Statistical analyses included ANOVA, correlation studies, and ROC curve analysis to assess FABP4’s diagnostic utility. RESULTS: Mean FABP4 levels were significantly higher in PAD patients with T2D (6.808 ± 0.6930 ng/mL) compared to both T2D patients (3.726 ± 0.4643 ng/mL) and healthy controls (2.947 ± 0.3948 ng/mL). ROC analysis confirmed FABP4’s diagnostic value for PAD (AUC = 0.8257, p<0.0001), with a threshold >3.95 ng/mL indicating PAD and 2.88–3.95 ng/mL indicating the T2D range. This threshold may be considered useful for the diagnosis of PAD as a novel approach in Indian population. FABP4 positively correlated with BMI, diastolic BP, and fasting glucose, while negatively correlating with systolic BP, total cholesterol, HDL, and LDL cholesterol. CONCLUSION: FABP4 may be a promising biomarker for identifying PAD in individuals with Type 2 diabetes in Indian population, with a threshold >3.95 ng/mL. This may be considered as the first Indian cohort threshold value for PAD diagnosis in diabetes.