Comparative Effects of Aspirin, Metformin and SGLT2 Inhibitors on Liver Enzymes, Lipid Profile, and FibroScan Findings in Non-Alcoholic Fatty Liver Disease

This was a single-center, open-label, parallel-group randomized controlled clinical trial conducted over 6 months in adults diagnosed with non-alcoholic fatty liver disease (NAFLD), currently referred to as metabolic dysfunction-associated steatotic liver disease (MASLD).

Participants were randomly allocated to one of three treatment groups:

• Aspirin group: aspirin 100 mg orally once daily for 6 months.
• Dapagliflozin group: dapagliflozin 10 mg orally once daily for 6 months.
• Metformin group: metformin 1000 mg orally once daily for 6 months.

The study was designed to compare the hepatic and metabolic effects of anti-inflammatory/antiplatelet therapy, SGLT2 inhibition, and insulin-sensitizing therapy in patients with NAFLD/MASLD.

Participants underwent clinical and laboratory assessment at baseline and after 6 months of treatment. Laboratory assessments included liver enzymes, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP), together with lipid-profile parameters, including total cholesterol, triglycerides, and high-density lipoprotein cholesterol (HDL-C).

Hepatic steatosis and liver stiffness were assessed noninvasively using vibration-controlled transient elastography (FibroScan). The controlled attenuation parameter (CAP, dB/m) was used to assess hepatic steatosis, while liver stiffness measurement (LSM, kPa) was used to assess liver stiffness/fibrosis-related changes.

The main study outcomes included changes from baseline to 6 months in FibroScan-derived CAP and LSM values, liver enzymes, and lipid-profile parameters. Additional metabolic and clinical outcomes included body weight, waist circumference, and other relevant metabolic indicators where available.

Statistical Analysis: Continuous variables were summarized using appropriate descriptive statistics. Within-group changes from baseline to 6 months were evaluated using paired statistical tests as appropriate. Comparisons among the three treatment groups were performed using analysis of variance (ANOVA) or corresponding non-parametric tests, as applicable. Analysis of covariance (ANCOVA) adjusting for baseline values was used when baseline differences were present. Appropriate post-hoc pairwise comparisons were performed where required. All statistical tests were two-sided, and a p-value <0.05 was considered statistically significant.

Inclusion criteria

if one or more the following are present:

• Diabetes mellitus, unless receiving only Dapagliflozin for treatment.
• Adult individuals (18-65 years) with a clinical diagnosis of NAFLD based on liver ultrasound
• No history of alcohol consumption or consumption within 3 months.
• Absence of other liver diseases.
• No significant renal or gastrointestinal issues that could interfere with treatment.

Exclusion criteria

Patients were excluded from our study if one or more the -following are present:

• Pregnancy or breastfeeding.
• Active chronic viral hepatitis or autoimmune liver disease.
• History of gastrointestinal bleeding or other contraindications for Aspirin.
• Severe renal insufficiency.
• Alcohol intake