NCT07338331

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

Comparison Between the Effect of Aspirin and SGLT2 Inhibitor Intake in Non-Alcoholic Fatty Liver on Liver Enzymes, Lipid Profile, and the Results of FibroScan

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Galala University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Non-alcoholic fatty liver disease (NAFLD) is a prevalent hepatic manifestation of metabolic syndrome, encompassing a spectrum of liver disorders from steatosis to non-alcoholic steatohepatitis (NASH), with potential progression to advanced fibrosis, cirrhosis, and hepatocellular carcinoma. Given the global health burden of NAFLD, therapeutic interventions targeting its pathophysiological mechanisms are crucial.

Detailed description

A randomized, controlled clinical trial will be conducted over 6 months with 80 participants diagnosed with NAFLD. Participants will be assigned to one of the groups including the Aspirin group (100 mg/day), and Empagliflozin 10 mg once daily. Primary outcomes include changes in liver enzymes, lipid profiles, and Fibroscan results, while secondary outcomes focus on clinical symptoms and metabolic indicators like body weight and waist circumference. Statistical Analysis: Paired t-tests will compare pre- and post-treatment values within each group, while independent t-tests will assess differences between groups. A significance level of p\<0.05 will be used.

Conditions

• Diabete Type 2
• Non Alcoholic Fatty Liver

Interventions

Type	Name	Description
DRUG	Aspirin	Participants received 100 mg of aspirin (aspirin protect®) as oral daily doses for 6 months.
DRUG	Dapagliflozin (10Mg Tab) along with standard medical therapy	Participants received 10 mg of dapagliflozin (Diaflozimet ®) as oral once-daily doses for 6 months.

Timeline

• Start date: 2023-04-04
• Primary completion: 2025-04-05
• Completion: 2025-09-19
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: Egypt