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

Galala University

Status: Completed

Conditions: Non Alcoholic Fatty Liver; Diabete Type 2

Treatments: Drug: Aspirin; Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07338331

Galala U

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

aspirin group

Experimental group

Description:

Participants were received 100 mg of aspirin as oral daily doses for 6 months.

Treatment:

Drug: Aspirin

Dapagliflozin group

Experimental group

Description:

Participants were received 10 mg of dapagliflozin as oral once-daily doses for 6 months.

Treatment:

Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy