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

Primary Purpose

Fatty Liver Disease, Fatty Liver

Status
Not yet recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Itopride
conventional therapy
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatty Liver Disease focused on measuring Itopride in Mafld

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maha Youssif Fekry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

control group

interventions: drug itopride

Arm Description

• control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy

• itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 14, 2023
Last Updated
August 19, 2023
Sponsor
October 6 University
Collaborators
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05966025
Brief Title
Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
Acronym
MAFLD
Official Title
Evaluation of the Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 28, 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
Collaborators
Beni-Suef University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective of this study is to determine the clinical benefits of itopride in improvement of MAFLD
Detailed Description
the study will evaluate the possible benefits of itopride when added to pateints with metabolic associated fatty liver disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver Disease, Fatty Liver
Keywords
Itopride in Mafld

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Experimental
Arm Description
• control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy
Arm Title
interventions: drug itopride
Arm Type
Experimental
Arm Description
• itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy
Intervention Type
Drug
Intervention Name(s)
Itopride
Intervention Description
itopride will be taken by pateints one time per day by dose 100 mg
Intervention Type
Drug
Intervention Name(s)
conventional therapy
Other Intervention Name(s)
Anti hypertensive druds, anti hyperlipidemic drugs
Intervention Description
will taken by patient in control group
Primary Outcome Measure Information:
Title
incidence of MAFLD
Description
Highly sensitive CRP in mg\L by ELIZA, Fibro scan in MHzby fibroscan apparatus, ALT,AST in unit\liter by blood test
Time Frame
"1 Year "
Secondary Outcome Measure Information:
Title
Incidence of mafld
Description
Decrease LDL in mg\dl, Triglyceride and total cholesterolin mg\dl ,HOMA-IR in mg\dl, IL6,TNF alpha in mg\l by eliza
Time Frame
" 1 Year"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maha y fekry, beclore
Phone
01111349592
Ext
october 6
Email
maha.youssif.ph@o6u.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Engy ah wahsh, Lecturer
Phone
01003095692
Ext
october 6
Email
engywahsh@o6u.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoda m rabea, A Professor
Organizational Affiliation
Beni-suaf university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yasmine m madney, Lecturer
Organizational Affiliation
Beni-suaf university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maha Youssif Fekry
City
Giza
ZIP/Postal Code
12573
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
maha y fekry, beclore
Phone
01111349592
Ext
october6
Email
maha.youssif.ph@o6u.edu.eg
First Name & Middle Initial & Last Name & Degree
Engy ah wahsh, lec o6u
Phone
01003095692
Ext
october6
Email
engywahsh@o6u.edu.eg
First Name & Middle Initial & Last Name & Degree
Hoda m Rabea, A professor
First Name & Middle Initial & Last Name & Degree
Yasmine m medney, lec

12. IPD Sharing Statement

Learn more about this trial

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

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