Metabolic dysfunction-associated steatohepatitis (MASH)
Conditions
Interventions
Control group:1. Standard treatment plan for diabetes
2. Placebo: 3 capsules (48mg), once a day, orally
3. Polyene phosphatidylcholine Capsules (Yishanfu)2 capsules (456mg)
Take orally three times a day with meals.
4. Vitamin E soft capsules (100mg), three times a day, orally.
Experimental Group:1. Standard treatment plan for diabetes
2. Three sipaglitazine tablets (4 8 mg), one day
Once, orally
Sponsors
Punan Hospital,Pudong New District, Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Participants' ages range from 18 to 75 years old (inclusive). 2. Patients who have been diagnosed with type 2 diabetes mellitus (T2DM) according to the Chinese diabetes diagnostic criteria, with HbA1c at screening =238db/m and E > 8; 4. Participants must be diagnosed as MASH (NAS activity score >=4 points, with at least 1 point each for steatosis, inflammation and balloon degeneration) through liver biopsy, and have stage 2 or above liver fibrosis (if a patient has undergone liver biopsy within 6 months before screening and the biopsy report meets the above inclusion criteria, they can be included in the study). 5. The weight was stable in the 3 months before enrollment (the weight change was less than or equal to 10% compared with the baseline); 6. Possess good comprehension and behavioral abilities, and be able to take the medication daily as required by the test. 7. Sign the informed consent form in accordance with the regulations of the local ethics committee;
Exclusion criteria
Exclusion criteria: 1. Women who consume more than 20 grams of ethanol per day and men who consume more than 40 grams of ethanol per day; 2. There is evidence suggesting the presence of other forms of chronic liver disease: a. Alcoholic liver disease B. Positive hepatitis B surface antigen (HBsAg) or hepatitis B DNA C. Positive hepatitis c virus (HCV) RNA or hepatitis C antibody (anti-HCV) d. Evidence of autoimmune liver disease e. Drug-induced liver disease defined based on typical medication history and medical history f. Suspected or confirmed liver cancer g. Any other type of liver disease other than MASH; 3. Uncontrolled T2DM (HbA1c >9.5%) or type 1 diabetes mellitus (T1DM) at the time of screening; 4. T2DM patients with a history of diabetic ketoacidosis, proliferative diabetic retinopathy, diabetic macular degeneration, or severe non-proliferative diabetic retinopathy requiring acute treatment; 5. Having suffered from the following cardiovascular diseases within 6 months prior to screening: a. Acute myocardial infarction (MI) B. Cerebrovascular accident (stroke) c. Unstable angina pectoris d. Hospitalization due to congestive heart failure (CHF) e New York Heart Association Functional Classification IV A history of active or untreated malignant tumors within 5 years, or clinically significant malignant tumors (excluding basal cell or squamous cell skin cancer, cervical carcinoma in situ or prostate carcinoma in situ); 6. Poorly controlled hypertension (systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg) 7. Impaired renal function, estimated glomerular filtration rate (eGFR) 2 weeks) systemic glucocorticoid treatment; 16. Had used drugs or alternative therapies aimed at promoting weight loss within three months prior to the screening; Prescription drugs or over-the-counter drugs; 17. Use of treatment targeting MASH for more than 2 weeks within 3 months prior to screening (such as GLP-1 receptor agonists, TZD analogues or PPAR pan-agonists, etc.); 18. Any other circumstances that the researchers believe will impede compliance or hinder the completion of the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of steatohepatitis and no worsening of liver fibrosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weight from baseline;Change in CAP values and liver stiffness values assessed by transient elastography from baseline (Fibroscan).;Mean change in blood test parameters compared to baseline;An improvement in liver fibrosis by >= 1 stage (NASH CRN fibrosis score) and no worsening of steatohepatitis;An improvement in liver fibrosis by >= 1 stage (NASH CRN fibrosis score) and NAS score decrease =2 points; | — |
Countries
China
Contacts
Public ContactHai Li
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed