Benefits of Trimetazidine in MASLD Patients

October 6 University60 enrolled

Overview

Objective of this study is to determine the clinical benefits of trimetazidine in improvement of MASLD

the study will evaluate the possible benefits of trimetazidine when added to pateints with metabolic associated fatty liver disease

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Metabolic Associated Fatty Liver Disease

Interventions

TrimetazidineDRUG

trimetazidine at dose 20 mg three times daily to be taken by intervention group

Conventional therapyDRUG

conventional therapy

PlaceboDRUG

placebo tablet (inert substance has the same shape and color of intervention) to be taken by control group only

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: participants were included if they met MASLD diagnostic criteria, which required imaging-confirmed hepatic steatosis (via abdominal ultrasound and CAP), along with metabolic factors (BMI ≥25 kg/m², diabetes/dysglycemia, blood pressure ≥130/85 mmHg, triglycerides ≥150 mg/dL, or reduced HDL-cholesterol) Exclusion Criteria: The study excluded those with * alternative steatosis causes (alcohol intake \>50 g/day women or \>60 g/day men * drug-induced injury, hepatitis C, Wilson disease). * Additional exclusion criteria covered ages below 18 years, pregnancy. decompensated cirrhosis, portal hypertension, hepatocellular carcinomas. * Trimetazidine contraindications (Parkinson's disease, parkinsonian symptoms, tremors, severe renal impairment), patients on statins, sodium glucose transporter 2 inhibitors (SGLT2), glucagon-like peptide 1(GLP1) were among the other exclusion criteria

Locations (1)

Beni-Suef university

Banī Suwayf, Beni Suweif Governorate, Egypt

Outcomes

Primary Outcomes

Highly sensitive CRP

Highly sensitive CRP in mg\\dl by chemiillusence.

Time frame: measured at baseline and at six months

liver Fibrosis and steatosis in db./m

liver Fibrosis and steatosis in db./m fibro scan and fibro cap apparatus

Time frame: measured at baseline and at six months

ALT and AST

ALT, AST in IU/L by blood test.

Time frame: measured at baseline and at six months

Controlled attenuation parameter (CAP)

A measure of hepatic fat accumulation using transient elastography (Fibro Scan); values typically range from 100 to 400 dB/m, lower values indicate improvement Unit of measure: dB/m.

Time frame: measured at baseline and at six months

FAST Score

Fibro Scan-AST score; anon-invasive score to assess the risk of progressive MASH (Metabolic dysfunction-associated steatohepatitis). lower scores indicate improvement Unit of measure: Unitless index (range 0-1)

Time frame: at baseline and at six months

Secondary Outcomes

LDL cholesterol

Decrease in LDL in mg\\dl,

Time frame: measured at baseline and at six months

Triglyceride and total cholesterol

Triglyceride and total cholesterol in mg\\dl

Time frame: measured at baseline and at six months

HOMA-IR

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.