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

NCT07338331 | Completed DMC

• 1 other identifier: Galala U
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabete Type 2; Non Alcoholic Fatty Liver

Keywords

Non-alcoholic fatty liver disease, Aspirin, Dapagliflozin, Liver enzymes, Lipid profile

Outcome Measures

Primary Outcomes (2)

• lipid profile and Fibroscan results

  * 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.

  6 months

• lipid profile and Fibroscan evalution

  * 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.

  6 months

Secondary Outcomes (1)

• indicators of metabolic improvement

  6 months

Study Arms (2)

aspirin group

EXPERIMENTAL

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

Drug: Aspirin

Dapagliflozin group

EXPERIMENTAL

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

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

Interventions

Aspirin DRUG

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

Also known as: aspirin protect®

aspirin group

Dapagliflozin (10Mg Tab) along with standard medical therapy DRUG

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

Also known as: Diaflozimet ®

Dapagliflozin group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galala University: lead

Study Sites (1)

Faculty of Pharmacy

Banī Suwayf, Beni Suweif Governorate, 0000, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease

Interventions

Aspirin; dapagliflozin; Tablets

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 13, 2026
• Study Start: April 4, 2023
• Primary Completion: April 5, 2025
• Study Completion: September 19, 2025
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)