## 4 Discussion
Of the 151 patients with diabetes for whom we obtained reliable measurements, the concordance between the NFS scores and the pSWE values was met in 134 patients (88.7%), with a prevalence of severe fibrosis (F3/F4) of 18.7% (n--25), while 81.3% (n--109) of patients were classified as not having severe fibrosis (F1/F2). Previous studies that used liver biopsies as the gold standard have shown that the percentage of severe fibrosis among patients with T2 DM ranges from 16.2% to 43.1% [41,42]. [PERSON] et al., who conducted a study that assessed the clinical and histopathological features of NAFLD, found that the prevalence of severe fibrosis was significantly higher in patients with T2 DM than in those without T2 DM (27.3 % vs. 13.3 %, \(p<\) 0.01) [43]. Moreover, an extensive meta-analytic systematic review of seven studies published between 2004 and 2017, which included 439 liver biopsies from patients with T2 DM, showed that the mean reported severe fibrosis prevalence was 22.01% (ranging from 3.3% to 50%) [44]. The clinical profile in our study is consistent with data from more extensive studies [45,46]. We found that BMI, waist circumference, serum triglycerides, AST, ALT, GGT, serum glucose, HbA1C, and HOMA-IR were significantly higher in patients with severe fibrosis. Moreover, these patients frequently exhibited metabolic syndrome. In light of this data, our study supports the notion that the prevalence of severe fibrosis, the main determinant of mortality in NAFLD, is higher in patients with metabolic alterations. Other studies found a bidirectional correlation between liver fibrosis and peripheral diabetic neuropathy, suggesting possible common etiological mechanisms [47, 48, 49]. When looking at the independent effect of each studied parameter on severe fibrosis, multivariate logistic regression identified that GGT values, age, BMI, HbA1C, and HOMA-IR were significantly associated with it. We found no statistically significant independent association with arterial hypertension, but in a large meta-analysis, [PERSON] et al. established that elevated blood pressure is a strong risk factor for rapid progression to severe fibrosis and cirrhosis [50]. The assessed outcomes could explain this difference; in our study, we evaluated the risk factors associated with the presence of severe fibrosis, while in [PERSON]'s meta-analysis, the primary outcome was the estimation of the fibrosis progression rate. The clinical score created in this research can help identify severe liver fibrosis in patients with T2 DM and support clinicians in deciding whether to send patients for a liver biopsy [51]. However, according to this score, clinical judgment, including liver biopsies, may still be needed for patients who are not found to have severe fibrosis. Nevertheless, this score would correctly classify 89% of patients with advanced fibrosis. The present study has several strengths. Our cohort was consecutively enrolled and described using clinical, laboratory, and pSWE parameters. In particular, we focused on documenting diabetes status (the duration of T2 DM, serum glucose, HbA1c, HOMA-IR, and insulin use), as this is a well-studied risk factor for advanced liver fibrosis. To the best of our knowledge, our study is one of few that evaluates the clinical, laboratory, and pSWE parameters of NAFLD and the links between them in a population at risk, such as those with T2 DM. However, there are some limitations to consider. This is a pilot study, conducted on a small study population, and more significant large-scale quantitative analyses are needed for validation and to assess the technical challenges of pSWE. As liver biopsy indication has decreased and the use of serum biomarkers and elastography imaging has become more frequent in recent years, conducting a liver biopsy was not feasible in our patients. In addition, our cohort study included a population of Caucasians, who showed a high prevalence of obesity and severe fibrosis.