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

Sponsor

October 6 University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05966025

Collaborator

Beni-Suef University (Other)

Enrollment

Location

Arms

14.2

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fatty Liver Disease Fatty Liver	Drug: Itopride Drug: conventional therapy	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 28, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

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: Itopride itopride will be taken by pateints one time per day by dose 100 mg Drug: conventional therapy will taken by patient in control group Other Names: Anti hypertensive druds, anti hyperlipidemic drugs

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: Itopride

itopride will be taken by pateints one time per day by dose 100 mg

Drug: conventional therapy

will taken by patient in control group

Other Names:

Anti hypertensive druds, anti hyperlipidemic drugs

Outcome Measures

Primary Outcome Measures

incidence of MAFLD ["1 Year "]
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 [" 1 Year"]
Decrease LDL in mg\dl, Triglyceride and total cholesterolin mg\dl ,HOMA-IR in mg\dl, IL6,TNF alpha in mg\l by eliza

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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