metabolic associated fatty liver disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 to 65 (including both 18 and 65 years old); 2. Meet the diagnostic criteria of metabolism-related fatty liver disease (MASLD); MASLD diagnostic criteria: According to the "Guidelines for the Prevention and Treatment of Metabolism-related (Non-Alcoholic) Fatty Liver Disease (2024 Edition)", B-ultrasound examination indicates fatty liver, and at the same time meets any of the following cardiovascular metabolic criteria: (1) Body mass index >23kg/m^2 or waist circumference >94cm for men and 80cm for women; (2) Fasting blood glucose >5.6mmol or a history of diabetes, or taking hypoglycemic drugs; (3) Blood pressure >130/85 MMHG or receiving antihypertensive drug treatment; (4) Triglycerides >1.7 mmol/ or taking lipid-lowering drugs; (5) HDL-C in men and women should be less than 1.0mmol/L and less than 1.3 mmol/L respectively, or take lipid-lowering drugs.
Exclusion criteria
Exclusion criteria: 1. Liver and gallbladder diseases suspected of having other causes through medical history and laboratory tests, including but not limited to: Hepatitis B or C virus infection, chronic alcoholic liver disease, drug-induced liver disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's disease, a 1-antitrypsin deficiency, liver cancer, and significant liver function abnormalities (ALT or AST >= 5×ULN or TBIL >=1.5×ULN), etc. 2. Excessive alcohol consumption for three consecutive months or more within one year prior to screening (men consuming an average of over 30 grams of ethanol per day, equivalent to 3.75 units of alcohol, and women consuming over 20 grams, equivalent to 2.5 units of alcohol: 1 unit = 285 mL of beer, or 25 ml of spirits, or 100 ml of wine); 3. Other clinical findings before screening show any clinically significant diseases (including but not limited to gastrointestinal, neurological, hematological, endocrine, tumor, lung, immune, and mental disorders) that are unstable or untreated. 4. There is a history of acute cardiovascular events, or the following cardiovascular and cerebrovascular diseases: patients who have undergone coronary angioplasty, stroke, transient ischemic attack, or coronary heart disease; 5. Currently taking medications that may cause steatosis or steatohepatitis (including aminotropin, methotrexate, hormones, tetracycline, tamoxifen, steroids, valproic acid, etc.); 6. Periodontal treatment or taking antibiotics within 3 months; 7. Use drugs that inhibit dental plaque within one month; 8. Severe infection within half a year; 9. Smoking more than five cigarettes a day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral microbial community structure;Liver fat fraction;Liver stiffness;Aspartate Aminotransferase;Total Cholesterol;Triglycerides;High-density lipoprotein cholesterol;Low-density lipoprotein cholesterol; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight;Body Fat percentage;Waist-to-Hip Ratio;Blood Glucose;Insulin Resistance index;Alanine Aminotransferase; | — |
Countries
China
Contacts
Beijing Friendship Hospital, Capital Medical University