Benefits of Trimetazidine in MAFLD Pateints (MAFLD)

Evaluation of Potential Benefits of Trimetazidine in the Management of Pateints With Metabolic Associated Fatty Liver Disease ( MAFLD)

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

Study Overview

• Status: Recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: conventional treatment; Drug: Furosemide or other alternatives , Niaspan or other alternatives; Drug: Trimetazidine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Maha y fekry, beclore; Phone Number: october 6 01111349592; Email: maha.youssif.ph@o6u.edu.eg
• Study Contact Backup: Name: Engy ah wahsh, Lecturer; Phone Number: october 6 01003095692; Email: engywahsh@o6u.edu.eg

Study Locations

• Egypt
  • October 6
    • Giza, October 6, Egypt, 12573
      • Recruiting
      • Maha Youssif Fekry
      • Contact: maha y fekry, beclore; Phone Number: october6 01111349592; Email: maha.youssif.ph@o6u.edu.eg
      • Contact: Engy ah wahsh, lec o6u; Phone Number: october6 01003095692; Email: engywahsh@o6u.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:Patients presented to hepatology clinic .

• Patients are diagnosed by ultrasonography and laboratory tests for liver and lipids.
• Patients with comorbidites like hypertension,diabetes,dyslipidemia, insuline resistance , increase in west circumstanses

Exclusion Criteria:Exclusion criteria included the presence of liver disease due to any of the following:

• viral hepatitis (HBV, HCV)
• acute systemic disease
• cystic fibrosis, coeliac disease
• alcoholism pateints
• autoimmune hepatitis, drug toxicity and drugs known to induce steatosis (e.g. valproate, amiodarone orprednisone)
• the use of nonsteroidal anti-inflammatory drugs,antibiotics,sglt2,dpp4,statins,glp1
• Patient with age below 18 or above 60

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: control group (conventional treatment); control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy	Drug: conventional treatment; conventional treatment will be taken in control group; Other Names: conventional treatment ( anti diabetic drugs and antihyperlipidimic drugs ); Drug: Furosemide or other alternatives , Niaspan or other alternatives; conventional treatment will be taken in control group; Other Names: conventional therapy
Experimental: interventions: drug trimetazidine; trinetazidine group Weight reduction and life style modification and receive (trimetazidine) 20 mg three times dialy for 24 weeks plus their conventional treatment	Drug: conventional treatment; conventional treatment will be taken in control group; Other Names: conventional treatment ( anti diabetic drugs and antihyperlipidimic drugs ); Drug: Furosemide or other alternatives , Niaspan or other alternatives; conventional treatment will be taken in control group; Other Names: conventional therapy; Drug: Trimetazidine; trimetazidine and conventional therapy; Other Names: furosemide or other alternative , niaspan or other alternative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence in mafld	Highly sensitive CRP in mg\L by ELIZA.	"1 Year "
incidence in mafld	Fibro scan in MHzby fibroscan apparatus	"1 Year "
incidence in mafld	ALT,AST in unit\liter by blood test.	"1 Year "

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of mafld	Decrease in LDL in mg\dl,	" 1 Year"
incidence of mafld	Triglyceride and total cholesterolin mg\dl	"1 Year "
incidence of mafld	HOMA-IR in mg\dl	"1 year "
incidence of mafld	IL6,TNF alpha in mg\l by eliza	"1 Year "

Collaborators and Investigators

• Sponsor: October 6 University
• Investigators: Principal Investigator: Hoda m rabea, Assistant Professor, Beni-suaf university

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: November 18, 2023
• First Posted (Estimated): November 21, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 18, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: trimetazidine in mafld
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Natriuretic Agents; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Membrane Transport Modulators; Diuretics; Vitamins; Vitamin B Complex; Sodium Potassium Chloride Symporter Inhibitors; Hypoglycemic Agents; Nicotinic Acids; Furosemide; Niacin; Trimetazidine
• Other Study ID Numbers: REC-H-phBSU-23059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No