European Journal of Cardiovascular Medicine

India, the seventh-largest and second-most populous country globally, faces a growing public health challenge with NAFLD due to rising obesity [1], T2DM, sedentary lifestyles, and increased consumption of calorie-dense foods. NAFLD, which includes NAFL and NASH , is often asymptomatic, and its prevalence in T2DM patients worldwide ranges from 34% to 94% [2]. Since liver biopsy is required for a definitive NAFLD diagnosis, the actual prevalence may be underestimated, as biopsies are typically only performed when necessary [3]. Studies on NAFLD prevalence among T2DM patients in India are limited, with no specific research in West Bengal using the CAP technique. Given India’s ethnic diversity, results from one region cannot reliably represent others [4]. NAFLD diagnosis can involve assessing alcohol intake history, liver enzyme levels (ALT, SGOT, GGT), and imaging for hepatic steatosis, with ultrasonography being more cost-effective than CT or MRI. Obesity, hypertension, dyslipidemia, and particularly T2DM are significant risk factors for NAFLD, often due to insulin resistance [5]. Studies have shown that NAFLD in combination with T2DM can lead to higher overall, liver-related, and cardiovascular mortality [6]. These risk factors are on the rise in Asian countries, possibly due to genetic predispositions and differences in body fat distribution compared to Caucasians, which increase susceptibility to insulin resistance even in those who are not severely obese [7]. In India, periodic screening for NAFLD among diabetics is uncommon, leaving many untreated. Addressing this knowledge gap and enhancing screening practices are essential to reduce the impact of NAFLD on the Indian population.

Aim

• To ascertain how common non-alcoholic fatty liver disease is and what variables put people at risk for developing it when they are recently diagnosed with T2DM.
• To determine how many patients with newly diagnosed T2DM have non-alcoholic fatty liver disease.
• To discover the possible biochemical, clinical, and demographic variables linked to NAFLD in the setting of newly diagnosed T2DM.

Design of Study: Cross-sectional study.

Period of the Study: September 2022- August 2024.

Study Population: At katihar medical college and hospital, 150 patients with non-alcoholic fatty liver disease who were recently diagnosed with T2DM and were seen in the outpatient and inpatient medical departments participated in this study.State of Bihar

Sample size

• Based on an expected prevalence of 59.57% in T2DM patients, the sample size will be determined.
• For the purpose of determining the suitable sample size, the subsequent formula can be used:
• n= Z2×p×(1−p)/ E2
• Assume for the sake of argument the following:
• Prevalence (p) = 0.5967 (The prevalence of NAFLD is 59.67% in type 2 DM patients)
• Margin of error (E) = 0.08 (8% margin of error)
• Confidence level = 95% (corresponding to a Z-score of approximately 1.96)
• Using the formula:
• n = (1.96)2×0.5967× (1−0.5967) / (0.08)2
• n =3.8416×0.5967×0.4033/0.0064
• n≈144.4

The anticipated sample size is around 150 participants, rounded to the nearest whole number.

Inclusion Criteria

Patients with FBS > 126 mg/dl, RBS > 200, or HbA1c > 6.5% who have recently been diagnosed with T2DM.

All patients must be at least 35 years old.

• Individuals of either gender
• Patients who did not partake in alcohol utilisation.

Exclusion Criteria

Those who have an alcohol consumption history, those on certain medications (such as amiodarone, oestrogen, or

• Hemochromatosis has been identified,
• Disease of Wilson
• Problems with the pancreas,
• Diabetic condition that has been diagnosed.

The patient is anti-HCV and has HBsAg.

Positive for ANA

K.F. Ring and S. Ceruloplasmin together

Methodology

The study was conducted at katihar medical college and hospital, under the Department of Medicine. This study included 150 abdominal ultrasound-diagnosed fatty liver patients from the Department of Medicine. We obtained ethical clearance from the Institutional Ethics Council and patient consent in writing. The study included patients who met the American Gastroenterology Association's standard criteria, including increased hepatic echogenicity, periportal intensity enhancement, and vascular wall hyperechogenicity.

• Grade 1: The fine echoes show a subtle, diffuse enhancement. The kidney's cortex seems dark in comparison to the liver. Diaphragm and intrahepatic artery boundaries can be seen normally.
• Grade 2: An increase in the fine echoes that is moderate and diffuse. Intrahepatic vascular and diaphragmatic visibility is slightly diminished.
• Grade 3: Significant enhancement of the minute echoes. Limited or nonexistent visibility of the diaphragm, intrahepatic arteries, and their boundaries. Once the patient gave their informed consent, a thorough evaluation including anthropometry, clinical tests, and a medical history was conducted.
• Blood sugar, HBsAg, anti-HCV, lipid profile, liver function tests, and complete blood counts were among the standard investigations performed on all trial participants.

Study-Required Investigations

• Blood Sugar Level - Refuse to eat / post prandial
• Lipid Profile - Total Cholesterol; S. S. Triglycerides; HDL; S. S. LDL, VLDL
• Liver Function Tests - SGPT (ALT); SGOT (AST); Total/Direct/Indirect SGOT/SGPT;
• Alkaline phosphates; Bilirubin; S. Proteins
• HbA1C in Diabetics

Then USG – abdomen to confirm Non-alcoholic fatty liver and to determine the grading will be repeated.

Statistical Analysis

In order to derive the right conclusions, all of the recorded data was analysed using proper diagrams, figures, and tables. The results were then thoroughly discussed. The data was analysed with the help of SPSS Inc., Chicago, USA; Version 26.0. Data that were considered continuous were offered as means with standard deviations (SD). Numbers and percentages were used to express categorical variables.

Table 1: Age Distribution

This study's age distribution is shown in Table 1. The average age of the study participants was 47.39 ±13.25 years, and the majority of them were between the ages of 41 and 50 (39.3%).

Table 2: Sex Distribution

The research population's distribution by sex is displayed in Table 3. The gender breakdown of the research participants revealed that women made up slightly more than half of the sample (54%). There were around 11.7 males for every 1 females in the sample.

Table 3: Grade of NAFLD

Grades I, II, and III fatty liver were found in 56.3%, 34.7 percent, and 9.3 percent of cases, respectively, in this investigation.

Table 4: Risk Factors of NAFLD

Since hypertension, obesity, and hyperlipidaemia are currently recognised as risk factors for NAFLD, they have been extensively studied in this work to determine their association with NAFLD. Hyperlipidaemia affected 36.7% of the 150 patients, hypertension 43.3%, and obesity 23.4%. Table 6 displays the data.

Table 5: Incidence of Metabolic Syndrome according to the Severity of NAFLD

The prevalence of metabolic syndrome as a function of NAFLD severity is shown in Table 8. In 84 cases of stage I NAFLD, metabolic syndrome was present in 50 (59.5%). In 52 cases of grade II NAFLD, it was in 33 (63.5%). In 14 cases of grade III NAFLD, it was in 4 (12.6%). As a result, grade II NAFLD has the highest metabolism syndrome prevalence.

Table 6: Distribution of the study participants according to BMI

The results are in, and 34.7% of the people surveyed fell under the healthy BMI range of 18.5–22.9 kg/m2. Among those patients, 42.0% had a BMI between 22.9 and 23.2. A class 1 obesity rate of 13.3% was indicated by a BMI ranging from 25.0-29.9 kg/m2. Class 2 obesity, defined as a BMI of 30 kg/m2 or more, affected 10% of the participants. The participants' average BMI was 26.14 ±3.22 kg/m2.

Table 7: Subject Distribution according to FBS

Table 11 demonstrates that FBS levels ranged from 100 to 125 mg/dl, with 13.3% of the 100 subjects having levels above 126 mg/dl and 50% falling in the 100-125 MSLD range. On average, there was 136.92 ±33.99 mg/dl of FBS.

Table 8: Subject Distribution Based on PPBS

According to their PPBS level, the study subjects are distributed according to Table 12. Among the study subjects, 30.7% had PPBS levels ranging from 140 to 199 mg/dl, 21.3% had levels below 140 mg/dl, and 48.2% had levels of 200 mg/dl or more. In terms of PPBS, the average level was 177.49 ±35.55 mg/dl.

Table 9: Study Participants Organised by Total Cholesterol Level

According to their serum cholesterol levels, the study patients are distributed as shown in Table 13. Total cholesterol levels between 150 and 199 mg/dl were found in 23.3% of the subjects in the study. Of those, 13.4% had total cholesterol levels of 200 mg/dl or higher. A total cholesterol level < 150 mg/dl was seen in 63.3% of the study individuals. At 185.24 ±61.29 mg/dl, the average total cholesterol level was found.

Table 10: Classification of Research Participants Based on Triglyceride Level

According to their serum triglyceride level, the study individuals are distributed as indicated in Table 14. Serum triglyceride levels between 150 and 199 mg/dl were found in 10.7% of the subjects tested. 26 percent of the participants had total cholesterol levels of 200 mg/dl or higher. A blood triglyceride level < 150 mg/dl was seen in 63.3% of the study individuals. Serum triglyceride levels averaged 217.35 ±98.82 mg/dl.

Table 11: Subject Distribution Based on Serum LDL Level

Of the people surveyed, 26.7% had LDL levels ranging from 100 to 160 mg/dl, as shown in Table 16. LDL levels of 160 mg/dl were found in 22% of the samples. The serum LDL level averaged out at 143.53 ±37.37 mg/dl.

Table 12: Average Liver Enzyme Concentrations

The average levels of liver enzymes in the research participants are shown in Table 17. There was an average of 33.21 ±14.48 U/L for AST, 36.64 ±9.94 U/L for ALT, and 0.88 ±0.18 for the AST: ALT ratio. The GGT level was 32.91 ± 9.17 U/L while the ALP level was 103.70 ± 33.89 U/L on average. Total protein was 7.16 ±0.52 mg/dl and total bilirubin was 0.81 ±0.18 mg/dl, according to the 56 | Page Results & Observations.

Fatty liver disease is characterised by hepatic macrovesicular fat accumulation, which increases liver weight by 5-10%. This group includes steatosis and other liver disorders. Hepatocellular carcinoma and other complications can result from fibrosis, cirrhosis, steatohepatitis, and portal hypertension. Alcoholic or non-alcoholic fatty liver disease is possible. NAFLD is more common among non-drinkers and connected to T2DM, obesity, and dyslipidaemia. Due to changing diet and living habits, NAFLD is rising in India from 9% to 53%. MGM Medical College showed that 58% of 150 NAFLD patients had metabolic syndrome, which includes high blood pressure, obesity, and hyperlipidaemia. The clinical characteristics showed that most patients were female and aged 41–50. The findings underline the importance of raising awareness of NAFLD and preventing it, especially as metabolic diseases become more common.  A study by [8] reported that 117 cases (58.5%) had impaired fasting glucose levels (> 100 mg/dL), a significant finding (p value < 0.0001). Fasting glucose levels were impaired in 63.38 percent, 86.36 percent, and 53.85% of metabolic syndrome and grades I, II, and III fatty liver disease patients. [9] discovered 72.4% of patients had impaired fasting glucose, Unlike [10] 9% metabolic syndrome patients, 57 (28.5%) developed frank diabetes (> 126 mg/dL) . The International Diabetic Federation recommends aggressive metabolic syndrome treatment to decrease the risk of type II diabetes and coronary vascular disease. A mean of 131.81 ± 26.69/ 80.10 ± 10.64 mmHg was found for 41% of patients, similar to [11, 12] 46.72%. As NAFLD deteriorated, metabolic syndrome patients were more likely to develop hypertension.

This study demonstrated that newly diagnosed type 2 diabetics have a high rate NAFLD). Since 56% of diabetics have NAFLD, it increases the risk of metabolic problems and liver consequences. In this demographic, NAFLD is linked to hypertension, hyperlipidaemia, and obesity, emphasising the necessity for comprehensive therapy. The strong link between metabolic syndrome and NAFLD severity urges early detection and treatment. As type 2 diabetes and its consequences develop, Indian doctors must start routine NAFLD tests in diabetic patients immediately. Healthcare policy reforms, public health education, and NAFLD awareness could reduce the disease's long-term impacts. Future studies using longitudinal designs can better understand NAFLD in type 2 diabetics and therapy success. The rise of type 2 diabetes and NAFLD must be addressed to improve public health and quality of life.

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