Benefits of Trimetazidine in MASLD Patients
- Conditions
- Metabolic Associated Fatty Liver Disease
- Interventions
- Registration Number
- NCT06140953
- Lead Sponsor
- October 6 University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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)
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group (conventional treatment + placebo tablet) Conventional therapy placebo tablet (inert substance) + Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy Placebo group (conventional treatment + placebo tablet) Placebo placebo tablet (inert substance) + Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy intervention group: drug trimetazidine Trimetazidine trimetazidine 20 mg three times Aday plus lifestyle modification intervention group: drug trimetazidine Conventional therapy trimetazidine 20 mg three times Aday plus lifestyle modification
- Primary Outcome Measures
Name Time Method Highly sensitive CRP measured at baseline and at six months Highly sensitive CRP in mg\\dl by chemiillusence.
liver Fibrosis and steatosis in db./m measured at baseline and at six months liver Fibrosis and steatosis in db./m fibro scan and fibro cap apparatus
ALT and AST measured at baseline and at six months ALT, AST in IU/L by blood test.
Controlled attenuation parameter (CAP) 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 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 Outcome Measures
Name Time Method LDL cholesterol measured at baseline and at six months Decrease in LDL in mg\\dl,
Triglyceride and total cholesterol measured at baseline and at six months Triglyceride and total cholesterol in mg\\dl
HOMA-IR measured at baseline and at six months HOMA-IR
IL6 and TNF alpha measured at baseline and at six months IL6 and TNF alpha in pg./ml by Eliza
Trial Locations
- Locations (1)
Beni-Suef university
🇪🇬Banī Suwayf, Beni-suef, Egypt
Beni-Suef university🇪🇬Banī Suwayf, Beni-suef, Egypt