Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD) (MAFLD)

Evaluation of the Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease

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

Study Overview

• Status: Not yet recruiting
• Conditions: Fatty Liver; Fatty Liver Disease
• Intervention / Treatment: Drug: conventional therapy; Drug: Itopride

Detailed Description

the study will evaluate the possible benefits of itopride 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
  • Giza, Egypt, 12573
    • 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
    • Principal Investigator: Hoda m Rabea, A professor
    • Principal Investigator: Yasmine m medney, lec

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

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
• suspicion of muscular dystrophy, alpha-1-antitrypsin deficiency
• metabolic inherited diseases
• autoimmune hepatitis, drug toxicity and drugs known to induce steatosis (e.g. valproate, amiodarone orprednisone).
• Patients were also excluded if body weight and carbohydrate metabolism were altered by the use of parenteral nutrition
• protein malnutrition
• previous gastrointestinal surgery
• structural abnormalitiesof the gastrointestinal tract or neurological impairment.
• the use of nonsteroidal anti-inflammatory drugs,antibiotics,sglt2,dpp4,statins,glp1
• probiotics or anti-secretory drugs capable of causing achlorhydria within 2 months preceding enrolmentwere also considered exclusion criteria.
• 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; • control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy	Drug: conventional therapy; will taken by patient in control group; Other Names: Anti hypertensive druds, anti hyperlipidemic drugs
Experimental: interventions: drug itopride; • itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy	Drug: conventional therapy; will taken by patient in control group; Other Names: Anti hypertensive druds, anti hyperlipidemic drugs; Drug: Itopride; itopride will be taken by pateints one time per day by dose 100 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: October 6 University
• Collaborators: Beni-Suef University
• Investigators: Principal Investigator: Hoda m rabea, A Professor, Beni-suaf university; Principal Investigator: Yasmine m madney, Lecturer, Beni-suaf university

Study record dates

Study Major Dates

• Study Start (Estimated): December 28, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 28, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Itopride in Mafld
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Lipid Regulating Agents; Antihypertensive Agents; Hypolipidemic Agents
• Other Study ID Numbers: REC-H-PhBSU-23006

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