Lean metabolic dysfunction associated fatty liver disease
Conditions
Interventions
Control Group:Metformin placebo + lifestyle intervention
Intervention Group:Metformin+lifestyle intervention
Sponsors
Jinan Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. 18.5=6.1mmol/L, or 2h postprandial blood glucose >=7.8mmol/L or HbA1c>=5.7%, or history of type 2 diabetes mellitus; Or Homeostasis model assessment-insulin resistance (HOMA-IR) >=2.5; (3), fasting serum Triglyceride (TG) >=1.70mmol/L, or receiving lipid-lowering drugs; (4). serum high-density lipoprotein =130/85 MMHG or on antihypertensive medication); 4.Liver fat content >=5% as determined by MRI-PDFF, as confirmed by central imaging before randomization; 5.Weight change <=5% within 3 months before screening; 6. HbA1c<=7% at screening and no previous treatment with antidiabetic drugs; 7. Subjects of childbearing potential agreed to use contraception as specified in the protocol throughout the study and for 3 months after the last treatment. Female subjects should not breastfeed; 8. They are willing to provide informed consent and to strictly abide by the requirements and restrictions of the informed consent and the protocol during the whole study period, including but not limited to: diet, exercise, lifestyle management, oral administration of study drugs as planned, keeping a study diary, and completing relevant questionnaires.
Exclusion criteria
Exclusion criteria: 1. Known allergy or contraindication to the active ingredient and/or excipients of metformin; 2.Use of weight-loss medications, metabolic surgery, or replacement therapy within 3 months before screening; Use of Chinese herbal medicine, other traditional medicines, health supplements, or meal replacements for weight loss or hypoglycemic effects; 3. Received chronic (> 2 weeks) systemic glucocorticoid therapy within 3 months before screening or was considered by the investigator to be likely to receive systemic glucocorticoid therapy within the next year; 4.High dose of vitamin E (>400IU) or pioglitazone within 3 months before screening; 5. Relevant drugs that may cause or worsen MASLD with the use of more than 14 consecutive days in the 6 months prior to screening, including but not limited to the following drugs: amiodarone, methotrexate, systemic oral glucocorticoids, tamoxifen, high-dose estrogens, anabolic steroids other than testosterone substitutes, valproic acid, tetracycline, and other known hepatotoxins; 6. Patients with hypothyroidism or hyperthyroidism; 7. Poorly controlled hypertension at screening, with resting systolic blood pressure >=160mmHg or diastolic blood pressure >=100mmHg; Or with renal artery stenosis or unstable blood pressure (including orthostatic hypotension, etc.); 8. Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, percutaneous coronary intervention, transient ischemic attack (TIA), cerebrovascular accident within 6 months before screening; Or a previous diagnosis of decompensated heart failure or NewYork heart association (NYHA) class III or IV heart failure; 9. A history of pathologic, symptomatic, or sustained tachycardia (e.g., atrial fibrillation, sustained supraventricular tachycardia, symptomatic nonsustained supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation; 10. Previous or existing liver disease with a cause other than MASLD, including but not limited to hepatitis B, hepatitis C, drug-induced liver disease, autoimmune liver disease, liver transplantation, primary biliary cholangitis, primary sclerosing cholangitis, Rey's syndrome, Wilson's disease, a-1-antitrypsin deficiency, hemochromatosis, or known bile duct obstruction; 11. Cirrhosis or a history of cirrhosis and/or a history of hepatic decompensation during the screening period; 12. Have a history of depression or a serious mental illness (e.g., schizophrenia, bipolar disorder, or other serious mood disorder or anxiety disorder) or other mental illness considered by the investigator to be inappropriate for participation in the study; 13. Patients with previous history of malignant tumor; 14. Positive for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV) antibody or hepatitis C virus (HCV) antibody or syphilis antibody at screening; 15. A history of heavy drinking in the 2 years prior to screening, defined as an average daily consumption of more than 2 units of alcohol for more than 3 consecutive months (1 unit ˜360 ml of 5% alcohol beer or 45mL of 40% alcohol liquor or 150 ml of 12% wine); 16. Laboratory test results at screening meet any of the following: (1). Glomerular filtration rate (eGFR) 3× Upper limit of normal value (ULN); (3). Total bilirubin (TBIL) > 1.5 mg/dL; 17. Contraindications to MRI: if the subject is implanted with a pacemaker, a metal heart valve, a magnetic material (such as a surgical cli
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver fat content; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function;Analysis of liver fibrosis;Glycated Hemoglobin;Fasting plasma glucose;Fasting insulin;Fasting C-peptide;Intestinal microbiota gene testing;Blood lipids;Body composition analysis;Body Weight;Height;Body Mass Index (BMI) ;Body Fat Percentage;Waist Circumference;Waist-to-height ratio(WHtR);Blood pressure;Uric Acid;Renal function;Age;Sex;Liver-related medical history;Metabolic Disease Profiles;Comorbidities;Thyroid function; | — |
Countries
China
Contacts
Public ContactYongfeng Song
Jinan Central Hospital
Outcome results
None listed