Evaluation of Potential Benefits of Trimetazidine in the Management of Patients With Metabolic Associated Steatotic Liver Disease (MASLD)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- October 6 University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Highly sensitive CRP
Study Overview
Brief Summary
Objective of this study is to determine the clinical benefits of trimetazidine in improvement of MASLD
Detailed Description
the study will evaluate the possible benefits of trimetazidine when added to pateints with metabolic associated fatty liver disease
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •participants were included if they met MASLD diagnostic criteria, which required imaging-confirmed hepatic steatosis (via abdominal ultrasound and CAP), along with metabolic factors (BMI ≥25 kg/m², diabetes/dysglycemia, blood pressure ≥130/85 mmHg, triglycerides ≥150 mg/dL, or reduced HDL-cholesterol)
Exclusion Criteria
- •The study excluded those with
- •alternative steatosis causes (alcohol intake >50 g/day women or >60 g/day men
- •drug-induced injury, hepatitis C, Wilson disease).
- •Additional exclusion criteria covered ages below 18 years, pregnancy. decompensated cirrhosis, portal hypertension, hepatocellular carcinomas.
- •Trimetazidine contraindications (Parkinson's disease, parkinsonian symptoms, tremors, severe renal impairment), patients on statins, sodium glucose transporter 2 inhibitors (SGLT2), glucagon-like peptide 1(GLP1) were among the other exclusion criteria
Arms & Interventions
Placebo group (conventional treatment + placebo tablet)
placebo tablet (inert substance) + Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy
Intervention: Conventional therapy (Drug)
Placebo group (conventional treatment + placebo tablet)
placebo tablet (inert substance) + Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy
Intervention: Placebo (Drug)
intervention group: drug trimetazidine
trimetazidine 20 mg three times Aday plus lifestyle modification
Intervention: Trimetazidine (Drug)
intervention group: drug trimetazidine
trimetazidine 20 mg three times Aday plus lifestyle modification
Intervention: Conventional therapy (Drug)
Outcomes
Primary Outcomes
Highly sensitive CRP
Time Frame: measured at baseline and at six months
Highly sensitive CRP in mg\\dl by chemiillusence.
liver Fibrosis and steatosis in db./m
Time Frame: measured at baseline and at six months
liver Fibrosis and steatosis in db./m fibro scan and fibro cap apparatus
ALT and AST
Time Frame: measured at baseline and at six months
ALT, AST in IU/L by blood test.
Controlled attenuation parameter (CAP)
Time Frame: measured at baseline and at six months
A measure of hepatic fat accumulation using transient elastography (Fibro Scan); values typically range from 100 to 400 dB/m, lower values indicate improvement Unit of measure: dB/m.
FAST Score
Time Frame: at baseline and at six months
Fibro Scan-AST score; anon-invasive score to assess the risk of progressive MASH (Metabolic dysfunction-associated steatohepatitis). lower scores indicate improvement Unit of measure: Unitless index (range 0-1)
Secondary Outcomes
- LDL cholesterol(measured at baseline and at six months)
- Triglyceride and total cholesterol(measured at baseline and at six months)
- HOMA-IR(measured at baseline and at six months)
- IL6 and TNF alpha(measured at baseline and at six months)
Investigators
Maha youssif
principal investigator
October 6 University