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OpenTrials
Completed

NCT Number: NCT07338331

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Pharmacy

Banī Suwayf, Beni Suweif Governorate, 0000, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

Participants received 100 mg of aspirin (aspirin protect®) as oral daily doses for 6 months.

Other names: aspirin protect®

Dapagliflozin (10Mg Tab) along with standard medical therapy

Drug

Participants received 10 mg of dapagliflozin (Diaflozimet ®) as oral once-daily doses for 6 months.

Other names: Diaflozimet ®

Primary outcomes

  1. lipid profile and Fibroscan results

    Time frame: 6 months

    • Changes in liver enzymes (AST, ALT, ALP, GGT) after 6 months.
    • Lipid profile (Total Cholesterol, LDL, HDL, Triglycerides) at baseline and after 6 months.
    • Fibroscan results (liver stiffness measurement) at baseline and after 6 months.
  2. lipid profile and Fibroscan evalution

    Time frame: 6 months

    • Changes in liver enzymes (AST, ALT, ALP, GGT) after 6 months.
    • Lipid profile (Total Cholesterol, LDL, HDL, Triglycerides) at baseline and after 6 months.
    • Fibroscan results (liver stiffness measurement) at baseline and after 6 months.

Secondary outcomes

  1. indicators of metabolic improvement

    Time frame: 6 months

    • Improvement in clinical symptoms (fatigue, discomfort).
    • Impact on body weight and waist circumference (as indicators of metabolic improvement).

Sponsors and collaborators

Lead sponsor

Galala University

Other

Registry information

Official study title

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

Acronym: AS-NAFLD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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