European Journal of Cardiovascular Medicine

Diabetes Mellitus (DM), particularly Type 2, is a growing public health challenge worldwide and especially in India, where its prevalence has shown a marked increase over the past three decades. By 2025, the number of diabetic individuals in India is projected to reach approximately 79 million [1].

The chronic hyperglycemia associated with Type 2 Diabetes Mellitus (T2DM) is known to contribute to both microvascular and macrovascular complications, including nephropathy, retinopathy, and cardiovascular disease [2][3]. While conventional cardiovascular risk factors such as hypertension, smoking, and dyslipidemia are well documented in diabetic populations, they do not fully account for the heightened cardiovascular morbidity and mortality observed in these patients [4].

Fibrinogen, an acute phase reactant and a key coagulation factor, has emerged as a novel biomarker of interest. Elevated plasma fibrinogen levels have been associated with increased blood viscosity, enhanced platelet aggregation, and vascular inflammation, thereby contributing to atherothrombosis [5][6]. Several studies suggest that fibrinogen levels are elevated in individuals with diabetes and that these levels correlate positively with poor glycemic control, as measured by hemoglobin A1c (HbA1c), and with markers of nephropathy such as microalbuminuria [7].

Furthermore, dyslipidemia—characterized by elevated triglycerides, total cholesterol, and low HDL cholesterol—has been linked to both diabetes progression and elevated fibrinogen concentrations. In this context, exploring the interplay between fibrinogen levels and traditional risk indicators could help elucidate the mechanisms behind the excess cardiovascular risk seen in diabetic populations [8].

 
The present study was undertaken to measure fibrinogen levels in patients with Type 2 Diabetes Mellitus and to evaluate their association with glycemic control and urinary albumin excretion. In addition, the study aimed to assess correlations between fibrinogen and other established risk factors, including hypertension, obesity, smoking, and lipid profile abnormalities.

Aims and Objectives

This study was conducted to investigate the role of plasma fibrinogen in patients with Type 2 Diabetes Mellitus and its association with key clinical parameters. The specific objectives were:

1. To estimate plasma fibrinogen levels in patients with Type 2 Diabetes Mellitus and compare them with non-diabetic controls.
2. To assess the association between fibrinogen levels and glycemic control as measured by HbA1c.
3. To evaluate the relationship between fibrinogen levels and urinary albumin excretion rate (microalbuminuria).
4. To analyze the correlation of fibrinogen with additional cardiovascular risk factors including hypertension, smoking, obesity, and lipid profile abnormalities.
5. To identify independent predictors of elevated fibrinogen levels using multivariate logistic regression.

This analytical cross-sectional study was conducted on a total of 100 individuals, comprising 50 patients diagnosed with Type 2 Diabetes Mellitus (based on WHO criteria) and 50 age- and sex-matched non-diabetic controls. The study was carried out after obtaining informed consent from all participants.

Inclusion criteria for the diabetic group included adults with a confirmed diagnosis of Type 2 Diabetes Mellitus. Individuals with known inflammatory, infectious, or hematological disorders were excluded to avoid confounding effects on fibrinogen levels. The control group consisted of healthy adults without a diagnosis of diabetes or other chronic illnesses.

All participants underwent a thorough clinical evaluation, including documentation of demographic details, duration of diabetes, smoking status, hypertension, and body mass index (BMI). Blood samples were collected under aseptic conditions for biochemical analyses.

Plasma fibrinogen levels were measured using the Clauss method. Glycemic control was assessed by measuring HbA1c using high-performance liquid chromatography (HPLC). Urinary albumin excretion was evaluated using spot urine samples for microalbumin estimation. Lipid profile parameters including total cholesterol, triglycerides, HDL, and LDL were measured using enzymatic methods.

The presence of diabetic retinopathy was assessed through fundoscopic examination, and cases were categorized into non-proliferative and proliferative types.

Statistical analysis was performed using appropriate software. Continuous variables were expressed as mean ± standard deviation. Categorical variables were presented as percentages. The relationship between fibrinogen levels and other clinical parameters was analyzed using correlation coefficients. Multivariate logistic regression was employed to identify independent predictors of elevated fibrinogen levels. A p-value < 0.05 was considered statistically significant.

Baseline Characteristics of Study Participants

A total of 50 patients with Type 2 Diabetes Mellitus were included in the study. The mean age was 58.4 years, with the largest proportion of patients (38%) in the 61–70 years age group. Males constituted 54% of the participants, while females made up 46%. Most participants (40%) had diabetes for more than 5 years, and the average duration of diabetes was 4.6 years. The BMI distribution showed 38% of participants were overweight and 2% were obese. Hypertension was reported in 40% and smoking in 26% of the patients. Retinopathy was observed in 42% of cases, with 38% showing non-proliferative and 4% proliferative changes. These baseline characteristics are summarized in the tables below.

Table 1: Age Distribution of Diabetic Patients

Table 2: Sex-wise Distribution

Table 3: Duration of Diabetes

Table 4: BMI Categories

Table 5: Fundus Findings in Diabetic Patients

Fibrinogen Levels in Diabetics vs. Controls

The mean fibrinogen level in diabetic patients was significantly higher than in non-diabetic controls. Diabetics had a mean fibrinogen level of 396.64 ± 164.73 mg/dL, whereas controls had 252.6 ± 79.26 mg/dL (p < 0.05). Furthermore, 26% of diabetics had fibrinogen levels above 500 mg/dL, while none of the controls reached this threshold. The detailed distribution of fibrinogen levels among cases and controls is summarized in the tables below.

Table 6: Mean Fibrinogen Levels in Diabetics and Controls

Table 7: Distribution of Fibrinogen Levels in Cases and Controls

Figure1: Bar chart comparing mean fibrinogen levels in diabetics vs. controls

Glycemic Control and Albumin Excretion

In the study population of 50 diabetic patients, 54% exhibited poor glycemic control with HbA1c levels greater than 7%. The mean HbA1c was not explicitly stated, but the association between HbA1c and fibrinogen was found to be statistically significant. Additionally, microalbuminuria was present in 50% of the diabetic cases, indicating early nephropathy.

Table 8: Glycemic Control and Microalbuminuria in Diabetics

Correlation of Fibrinogen with Glycemic and Renal Markers

Correlation analysis was conducted to examine the relationship between fibrinogen levels and various clinical markers. Strong positive correlations were observed between fibrinogen and HbA1c, microalbuminuria, and duration of diabetes. All correlations were statistically significant (p < 0.05), suggesting that elevated fibrinogen is associated with poor glycemic control, longer diabetes duration, and renal impairment.

Table 9: Correlation Coefficients between Fibrinogen and Clinical Markers

 Association of Fibrinogen with Risk Factors

The association of fibrinogen levels with traditional cardiovascular and diabetic risk factors was examined. Significant associations were found with dyslipidemia and diabetic retinopathy. Although fibrinogen levels were higher among hypertensives and smokers, these differences were not statistically significant.

Table 10: Association of Fibrinogen with Risk Factors

Multivariate Analysis of Predictors of Fibrinogen Elevation

A multivariate logistic regression analysis was performed to identify independent predictors of elevated fibrinogen levels (>400 mg/dL) among diabetic patients. The analysis revealed that duration of diabetes greater than 5 years, elevated total cholesterol, and presence of microalbuminuria were statistically significant predictors. HbA1c levels above 7% also showed a significant trend, while triglyceride levels showed borderline significance.

Table 11: Multivariate Logistic Regression Analysis of Predictors of Elevated Fibrinogen Levels