Non-alcoholic fatty liver disease (NAFLD) Digestive System Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Patients will be stratified based on the presence or absence of diabetes. Randomisation code will be generated using online software using block randomisation. Specific treatment will be assigned usin
Sponsors
TWINS Digital Services India pvt ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with NAFLD (either ELF score > 7.7 or MRE with kPa 2.5 to 5) or with a histological diagnosis of NASH (biopsy < 6 months old) 2. Age =18 years of age of either gender 3. BMI 19 kg/m² and above 4. Non-diabetic or diabetic (HbA1c <9%) on a stable dose of antidiabetic medications for the last 3 months 5. Willing to provide written informed consent and comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Those with a history of significant alcohol consumption. Significant alcohol intake is considered when alcohol consumption >7 standard drinks/week (70 g ethanol) in women and >14 standard drinks/week (140 g ethanol) in men (according to Asia-Pacific Guidelines) 2. AUDIT score >8 indicating harmful alcohol consumption 3. Patients with a diagnosis liver disease due to other etiologies such as alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson’s disease, a1-antitrypsin deficiency 4. Those with clinical evidence of hepatic decompensation such as a history of ascites, esophageal bleeding varices, or spontaneous encephalopathy 5. Those with evidence of portal hypertension such as low platelet counts (180 mmHg or diastolic blood pressure (DBP) >100 mmHg) 10. Patients with a history of clinically significant heart disease (New York Heart Association (NYHA) Class greater than grade II), peripheral vascular disease (history of claudication), or diagnosed pulmonary disease 11. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study 12. Change in body weight more than 5% in the last 3 months 13. History of malignancy in the last 5 years 14. Active, serious medical disease with a likely life expectancy <2 years 15. Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer, prior to randomization 16. Patients on supplements for weight loss, pioglitazone, vitamin E 17. Pregnant and lactating women and postpartum up to 2 years 18. Those with contraindications for MR elastography 19. Any other condition that, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Fibrosis score and hepatic fat content measured by magnetic resonance elastography (MRE) at 1 year 2. Liver fibrosis assessed using enhanced liver fibrosis (ELF) scores measured from baseline to the end of 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fibrosis score and hepatic fat content measured using transient elastography at baseline, day 180, day 360, day 540, day 720 and day 900 2. Liver fibrosis assessed using enhanced liver fibrosis (ELF) scores at 2 years 3. Metabolic changes measured using: 3.1. Fasting plasma glucose at baseline, day 30, day 60, day 90, day 180, day 270, day 360, day 450, day 540, day 630, day 720, and day 900 3.2. Insulin, lipid profile, hemoglobin A1c at baseline, day 90, day 180, day 270, day 360, day 450, day 540, day 630, day 720, and day 900 3.3. Adiponectin at baseline, day 180, day 360, day 540, day 720, and day 900 4. Non-invasive markers for fat and fibrosis: 4.1. Fat assessed using the Framingham Steatosis Index (FSI), Fatty Liver Index (FLI), NAFLD liver fat score 4.2. Fibrosis assessed using the AST to platelet ratio index (APRI), Fibrosis-4 score, NAFLD fibrosis score Measured at baseline and every 3 months until 2 years 5. Quality of life measured using chronic liver disease questionnaire for nonalcoholic steatohepatitis (CLDQ-NASH), EQ 5D at baseline and every 3 months until 2 years 6. Microbiome status measured using whole genome metagenomic sequencing at day 1, day 30, day 90, day 360, day 720, and day 900 | — |
Countries
India
Contacts
Public ContactNagashri;Teju M;Velkoor
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Outcome results
None listed