Metabolic-associated steatotic liver disease (MASLD) patients Metadoxine Metabolic-associated Steatotic Liver Disease Randomized controlled trial Fatty liver disease Adverse event
Conditions
Interventions
1.) Participating patients will be given informed consent.
2.) Computer-generated blocking randomization will be done to randomized patients into Group 1 oral metadoxine tablet 500 mg three times dail
Experimental Drug,Placebo Comparator Drug
Metadoxine 500 mg,Placebo
Sponsors
Pacific Healthcare (Thailand) CO.LTD.
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. > 20 years of age 2. Diagnosed with MASLD and had proven steatosis by quantitative fat by MRI >=6%. Criteria for the diagnosis of MASLD 1. Patients who have hepatic steatosis on radiologic findings or histopathology and presence of at least one of the following metabolic criteria. 1.1) BMI >= 23 kg/m2 or waist circumference >94 cm (M)/80 cm (F) 1.2) Fasting serum glucose >= 100 mg/dL or 2-hour post-load glucose levels >= 140 mg/dL or HbA1C >= 5.7% or type 2 diabetes or treatment for type 2 diabetes 1.3) Blood pressure >= 130/85 mmHg or specific antihypertensive drug treatment 1.4) Plasma triglyceride >= 150 mg/dL or lipid lowering treatment 1.5) Plasma HDL-cholesterol <= 40 mg/dL (M) / 50 mg/dL (F) or lipid lowering treatment
Exclusion criteria
Exclusion criteria: 1) Uncontrolled diabetes (HbA1c >8.0%) 2) Alcohol intake >20 g/day for men and > 10 g / day for women (1-2 drinks per day) within the previous 10 years or >10 g/day within the previous year or >10 g/day and binge drinking 3) Evidence of other forms of liver disease, including hepatitis B (positive serum hepatitis B surface antigen), hepatitis C infection (positive anti-HCV), autoimmune hepatitis, drug-induced liver disease, biliary duct obstruction based on imaging studies; history of gastrointestinal bypass or use of drugs known to cause hepatic steatosis (e.g., amiodarone, valproate, tamoxifen, methotrexate, steroids) 4) Recent initiation or change of antidiabetic drugs that influence liver fat, including thiazolidinediones, GLP-1 receptor agonists, and SGLT-2 inhibitor, within 90 days of randomization. 5) Recent initiation or change of antidiabetic drugs that influence insulin sensitivity within 90 days of randomization, including metformin, and thiazolidinediones (doses of insulin can change, when patients is on insulin for >90 days) 6) Evidence of cirrhosis (on basis of MRI) or hepatocellular carcinoma 7) HIV infection 8) Active substance abuse 9) Pregnant or trying to become pregnant. 10) Parkinsonism currently treated with levodopa. 11) Renal insufficiency (eGFR of less than 60 ml/min/1.73m2) 12) Known hypersensitivity or allergy to metadoxine 13) Uncontrolled medical illnesses including recent myocardial infarction, COPD GOLD stage 4 or 5 14) History of food supplements known to have impact on the liver within 30 days of randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of steatosis improvement 16 weeks MRI fat - fraction | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect on liver fibrosis 16 weeks MRE,To evaluate the adverse effects / adverse drug 16 weeks Adverse event,Body composition 16 weeks BIA,Qualitu of life 16 weeks HRQOL | — |
Countries
Thailand
Contacts
Public ContactKanokwan Pinyopornpanish
Faculty of Medicine, Chiang Mai University
Outcome results
None listed