Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
Phase 2
Not yet recruiting
- Conditions
- Fatty LiverFatty Liver Disease
- Interventions
- Drug: conventional therapy
- Registration Number
- NCT05966025
- Lead Sponsor
- October 6 University
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description interventions: drug itopride Itopride • itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy interventions: drug itopride conventional therapy • itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy control group conventional therapy • control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Maha Youssif Fekry
🇪🇬Giza, Egypt