Non-alcoholic fatty liver disease (NAFLD) is a leading global health concern, characterized by the accumulation of fat in the liver in individuals who consume little or no alcohol. Affecting approximately 25% of the global population, NAFLD is now the most common chronic liver condition in both developed and developing countries1. It exists on a spectrum ranging from simple steatosis to non-alcoholic steatohepatitis (NASH), the latter of which can progress to fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). The rise in NAFLD prevalence closely parallels the global obesity epidemic and increasing rates of metabolic disorders, especially type 2 diabetes mellitus (T2DM), obesity, and dyslipidemia.2 NAFLD has been reported to affect up to 90% of individuals with T2DM and about 60–80% of obese individuals, highlighting the condition's strong association with metabolic dysfunction. The term “metabolic dysfunction-associated fatty liver disease” (MAFLD) has been proposed to reflect the close relationship between fatty liver and metabolic syndrome. NAFLD is recognized as not only a liver-specific issue but also a significant contributor to extrahepatic complications, including cardiovascular disease, chronic kidney disease, and microvascular complications such as diabetic retinopathy.3 Patients with both NAFLD and T2DM are nearly twice as likely to experience cardiovascular events. Therefore, early diagnosis and monitoring of liver health in diabetic patients are vital for preventing progression to severe liver disease and managing systemic complications. Geographically, the prevalence of NAFLD varies4. In South Asia, the Middle East, and parts of Latin America, the prevalence exceeds 30%, while it remains moderate (23–27%) in North America, Europe, and East Asia. Africa has the lowest reported prevalence at around 14%. In India, NAFLD affects approximately 9–32% of the population, with higher rates observed in urban areas and among individuals with metabolic syndrome. South Asians are particularly vulnerable due to unique fat distribution patterns and higher cardiovascular risk, making ethnicity-specific considerations important for diagnosis and management5.Liver biopsy remains the diagnostic gold standard for NAFLD, identifying steatosis when ≥5% of hepatocytes contain fat. However, due to its invasive nature, it is impractical for widespread screening. Instead, non-invasive methods like FibroScan are increasingly used. FibroScan utilizes transient elastography to measure liver stiffness (LSM) and controlled attenuation parameter (CAP), offering a reliable assessment of liver fibrosis and fat content. The FAST score, derived from LSM, CAP, and AST levels, provides a comprehensive, non-invasive measure of liver health6.Given the high risk and burden of NAFLD among T2DM patients, particularly in India, timely identification and monitoring using non-invasive tools like FibroScan are essential. Early diagnosis not only aids in preventing progression to cirrhosis and HCC but also allows better management of comorbidities associated with metabolic dysfunction7. Despite the growing prevalence, data on NAFLD in Indian diabetic populations remain limited. Therefore, studies assessing the prevalence and severity of NAFLD using tools like FibroScan are critical for guiding public health strategies and clinical interventions8.

AIM

To estimate the burden of NAFLD and identify patients at risk of progressive disease in Type 2 Diabetes Mellitus using non-invasive FibroScan-AST score.

This is a prospective observational hospital-based study conducted over 18 months at Mahatma Gandhi Medical College & Hospital, Jaipur, following IEC approval. The study will include patients admitted with type 2 diabetes mellitus and newly diagnosed cases during the study period. Inclusion criteria are age over 18 years, confirmed type 2 diabetes, fatty liver on ultrasound (USG), and willingness to participate. Exclusion criteria include alcoholic liver disease, ascites, pregnancy, viral hepatitis (HBsAg, HCV antibodies, HBV DNA, HCV RNA positive), and type 1 diabetes mellitus. These criteria ensure the focus remains on NAFLD associated with type 2 diabetes. The study aims to estimate the burden of NAFLD and identify patients at risk of progressive disease. Non-invasive tools such as FibroScan and AST score will be used for assessment.

Table 1: Baseline characteristic of cases

Above table shows that out of 80 patients 16 patients belonged to <50 years age group , 23 patients belonged to 50-60 years age group, 31 patients belonged to 60-70 years and 10 patients belonged to >70 years age group.

Table 2: Prevalence of NAFLD

                               Above table shows that prevalence of NAFLD in present study was 75%.

Table 3: BP profile, Waist circumference and BMI profile of cases as per NAFLD status

Above table shows that the mean DBP was significantly higher in DM patients with NAFLD but SBP was comparable in DM patients without NAFLD. The mean waist circumference and BMI were significantly higher in DM patients with NAFLD as compared to DM patients without NAFLD.

Table 4: Dislipidaemia profile and Metabolic syndrome profile of cases as per NAFLD status

Above table shows that the prevalence of dyslipidemia was significantly higher in DM patients with NAFLD as compared to DM patients without NAFLD. Above table shows that the prevalence of Metabolic Syndrome was significantly higher in DM patients with NAFLD as compared to DM patients without NAFLD.

Table 5: Blood sugar and HBA1C profile of cases as per NAFLD status

Above table shows that the mean blood sugar and HBA1C were significantly higher in DM patients with NAFLD as compared to DM patients without NAFLD.

Table 6: LFT profile of cases as per NAFLD status

Above table shows that mean ALT were significantly higher in DM-2 patients with NAFLD as compared to DM-2 patients without NAFLD (35.77±8.88 versus 20.85±3.54 U/L). The mean AST were significantly higher in DM-2 patients with NAFLD as compared to DM-2 patients without NAFLD (27.97±4.29 versus 21.40±3.07 U/L) and mean GGT were significantly higher in DM-2 patients with NAFLD as compared to DM-2 patients without NAFLD (48.87±10.75 versus 34.30±5.84 U/L).

Table 7: Fibrosis stage profile of cases as per NAFLD status

In present study out of 60 patients of NAFLD with DM 36 belonged to F2 grade of fibrosis, 22 belonged to F3 grade of fibrosis, and 2 belonged to F4 grade of fibrosis.

Table 8: CAP profile, LSM profile and Comparison of FAST Score as per NAFLD status

Above table shows that mean CAP were significantly higher in DM-2 patients with NAFLD as compared to DM-2 patients without NAFLD (274.00±27.60 versus 206.05±12.13 dB/m).That mean LSM were significantly higher in DM-2 patients with NAFLD as compared to DM-2 patients without NAFLD (9.43±1.19 versus 5.78±.81 kPa).FAST Score were significantly higher in DM-2 patients with NAFLD as compared to DM-2 patients without NAFLD (0.28±0.09 versus 0.08±.03).

The term non-alcoholic fatty liver disease (NAFLD) is commonly categorized by accumulation of fat in liver which changes from simple steatosis to steatohepatitis, cirrhosis and hepatocellular carcinoma (HCC) in lack of excessive alcohol intake. NAFLD is the most common cause of persistently abnormal liver enzymes (AST and ALT).

In present study out of 80 patients 60 (75%) have NAFLD. Tran Thi Khanh Tuong et al.(2020) in their study found a high prevalence of NAFLD of 73.3%, including more than one-third of severe steatosis9.

In present study we found significant association between NAFLD with BMI, Obesity and Metabolic syndrome. Fabbrini E et al.(201010,  in their study found that Type 2 Diabetes Mellitus (T2DM) patients seem to have an enlarged risk of developing NAFLD than non-diabetic subjects and certainly have higher risk of increasing fibrosis and cirrhosis. T2DM surges the risk of liver associated death by up to 22-fold in patients with NAFLD. The prevalence rate of NAFLD in T2DM is estimated to be in the range of 12.5% to 87.5% in India. A large number of patients of NAFLD have a normal liver enzyme profile and the entire histologic spectrum of NAFLD may be seen in such patients11.

There are various reported prevalence rates of NAFLD in diabetes depending on different methods used to evaluate the liver. Liver biopsy is considered the ―gold standard‖ for both steatosis and fibrosis assessment. However, this is an invasive procedure with rising risk of complications. Abdominal ultrasonography was used to detect hepatic steatosis by most of the previous research, which is an inexpensive and widely available equipment. However, liver ultrasound may be inadequately accurate if there is less than 33% hepatic fat accumulation 12.

Recently, FibroScan with CAP measurement is a novel non-invasive, easy-to-perform tool developed to assess both hepatic steatosis and fibrosis simultaneously with high sensitivity and specificity. Screening for NAFLD in T2DM individuals using FibroScan/CAP is recommended in the latest Asia–Pacific Working Party on Non–Alcoholic Liver Disease guidelines13 prevalence of NAFLD in DM-2 patients were significantly associated with BMI, Obesity and Metabolic syndrome which is in agreement with results of present study.

In present study we found significant association between NAFLD with Dyslipdemia. Total Cholesterol, and TG, were significantly higher in DM-2 patients with NAFLD as compared to DM-2 patients without NAFLD.Similarly Kwok et al.(2015)14 in their study found that significant association between NAFLD with Dyslipdemia which is in agreement with results of present study.

In present study we found significant association between NAFLD with derangement of liver enzymes. AST, ALT and GGT were significantly higher in DM-2 patients with NAFLD as compared to DM-2 patients without NAFLD.Similarly Fabbrini E et al.(2010)10 in their study found that AST, ALT and GGT were significantly higher in DM-2 patients with NAFLD as compared to DM-2 patients without NAFLD which is in agreement with results of present study.

In present study the mean FAST Score were significantly higher in DM-2 patients with NAFLD as compared to DM-2 patients without NAFLD. Similarly Hideki Fujii et al15in their study found that the mean FAST Score were significantly higher in patients with NAFLD as compared to patients without NAFLD which is in agreement with results of present study.

In present study 15% (N=12) patients have FAST Score in range of 0.35-0.67 which indicates that these patients are prone to intermediate risk for progression of NAFLD and therefore should be routinely monitored in follow-up.

FibroScan not only assesses fibrosis (LSM) but also grades steatosis using CAP. By incorporating serum AST with FibroScan-derived parameters of LSM and CAP, the FAST score allows the simultaneous assessment of steatosis (CAP), inflammation (AST) and fibrosis (LSM). Given the similarities in the scoring parameters, the FAST score can be looked upon as a noninvasive counterpart of the biopsy.

NAFLD is an important but often overlooked disease. Management of NAFLD requires knowledge of its stage. Patients with NAFLD are at an increased risk of advanced fibrosis than those without NAFLD. The present study has shown that DM-2 patients have a high prevalence of NAFLD, Metabolic syndrome, Obesity, Dyslipidemia, higher HBA1C, higher FAST Score predicts a high degree of liver stiffness and such patients should be subjected to periodic LSM measurements to record the progression.

This study highlights the importance of using the FAST score to assess risk of NASH and fibrosis in type 2 diabetic patients with NAFLD. Out of 80 patients, 12 (15%) had elevated FAST scores (≥ 0.35), all in intermediate or advanced stages of steatosis and fibrosis. No early-stage patients showed elevated scores. The findings suggest that the FAST score is a valuable, non-invasive tool to identify at-risk individuals who may benefit from regular liver stiffness monitoring. The study recommends routine NAFLD screening and follow-up in T2DM patients, especially those with intermediate FAST scores (0.35–0.67), to help prevent disease progression.

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