Metabolic Associated Fatty Liver Disease
Conditions
Interventions
Experimental group 1:Rifaximin treatment
Experimental group 2:Metformin treatment
Experimental group 3:Rifaximin-metformin treatment
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Willing to sign the informed consent form. (2)Aged 18 to 75 years, gender is not limited. (3)Patients with a previous diagnosis of fatty liver within 6 months.(4) There is less than one of the following metabolic abnormality criteria: overweight or obesity (BMI >= 23kg/m^2), type 2 diabetes (T2DM) or clinical evidence of metabolic dysfunction. Metabolic dysfunction refers to the presence of at least two of the following abnormal metabolic indicators: A The waist circumference of men is >= 90cm, and the waist circumference of women is >= 80cm. B Systolic/diastolic blood pressure >= 130/85mmHg, and (or) those who have been diagnosed with hypertension and treated. C Fasting plasma triglyceride >=1.7mmol/L (150mg/dl) or those who have been diagnosed and treated. D Fasting plasma HDL-C = 2.5. G Plasma high-sensitivity C-reactive protein (hs-CRP) > 2 mg/L. (5)Liver fat content = 8% measured by MRI proton density fat fraction (Magnetic resonance imaging-estimated proton fat fraction, MRI-PDFF).
Exclusion criteria
Exclusion criteria: 1. Patients with cirrhosis diagnosed by clinical, laboratory, imaging examination and/or liver biopsy; 2. Chronic liver disease with other etiologies confirmed by medical history or laboratory tests: viral (type B or C, etc.), autoimmune liver disease, alcoholic liver disease (more than 20g/day for women, more than 30g/day for men), drug-induced liver disease, hepatolenticular degeneration, antitrypsin-1 genetic deficiency and idiopathic hemochromatosis and other liver diseases; 3. Other causes of hepatic steatosis have been confirmed by medical history or laboratory tests; drugs (tamoxifen, amiodarone, sodium valproate, methotrexate, glucocorticoids, olanzapine), total Parenteral Nutrition, Hypothyroidism, Inflammatory Bowel Disease, Cushing's Syndrome, Celiac Disease, ß-Lipoprotein Deficiency, Lipid Atrophic Diabetes, Moriac Syndrome, anterior pituitary hypofunction, hypogonadism, polycystic ovary syndrome, etc.; 4. Use of drugs that alter intestinal flora in the past 4 weeks, such as lactulose, systemic antibiotics, various types of intestinal microecological preparations or cholestyramine, etc.;5. In the past 4 weeks, the following drug doses have been used or changed, such as hepatoprotective drugs, bates, statins, antihypertensive drugs, etc.6. Drugs that may affect MAFLD have been used in the past 12 weeks: vitamin E, omega-3 fatty acids, pioglitazone, glucagon-like peptide-1 receptor agonist GLP-1 analogues, dipeptidyl peptidase IV inhibitors, opidocholic acid, glucose cotransport protein 2 (sodium-glucoseco-transporter2,SGLT2) inhibitors, etc.; antiobesity drugs or herbs, vitamins and over-the-counter drugs or supplements that may affect body weight. Drugs that have effects on blood glucose: biguanides, thiazolidinediones, insulin, intestinal insulin analogues, a-glucosidase inhibitors, sulfonylurea secretion enhancers, non-sulfonylurea secretion enhancers and so on. 7. Patients whose blood sugar is difficult to control: HbA1c > 9%, or fasting blood glucose = 11.1mmol/L, or C-peptide 160 kg or BMI = 30 kg/m2. 8. Patients with severe jaundice (serum Tbil level >= 85 µmol/L) or obvious renal insufficiency (serum Cr >= 1.2 ULN); 9. Those who have undergone bariatric surgery; 10. Diagnosed or suspected to be combined with malignant tumor; 11. Combined with systemic inflammatory diseases (such as connective tissue diseases); or biliary tract, pancreatic diseases; or chronic or acute infection; or serious diseases such as cardiovascular, pulmonary and hematopoietic systems; or history of myocardial infarction or stroke within 6 months; or patients with mental illness are still taking antipsychotic drugs within the last 3 months.; 12. HIV-infected persons; 13. Known allergic to rifaximin; 14. There are contraindications to MRI, such as metal implants in the body, claustrophobia or body size exceeding the imaging room capacity, etc.; 15. Pregnant and lactating women, women who do not rule out the possibility of pregnancy, or those who have a pregnancy plan. 16. Those who have participated in other drug trials within 3 months; 17. Other researchers believe that the participants are not suitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of liver fat content based on MRI measurement;Changes in insulin resistance assessed using a homeostatic model (HOMA-IR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of other indexes of liver function;Other imaging examinations;Changes of liver fat noninvasive scoring system;Improvement of systemic metabolic indexes; | — |
Countries
China
Contacts
Public ContactYin Chuan
Shanghai Changzheng Hospital
Outcome results
None listed