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

Galala University80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabete Type 2 Non Alcoholic Fatty Liver

Interventions

AspirinDRUG

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

Dapagliflozin (10Mg Tab) along with standard medical therapyDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Pharmacy

Banī Suwayf, Beni Suweif Governorate, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 6 months

lipid profile and Fibroscan evalution

Time frame: 6 months

Secondary Outcomes

indicators of metabolic improvement

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

Time frame: 6 months

Data from ClinicalTrials.gov

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