Metabolic Dysfunction Associated Steatotic Liver Disease
Conditions
Interventions
Group 1:Acupuncture + 2Hz Electroacupuncture
Group 2:Acupuncture + 100Hz Electroacupuncture
Group3:Non-acupoint + Superficial insertion
Sponsors
Beijing Friendship Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18 to 65 years 2. according to the criteria for MASLD 3. MRI-PDFF = 8% on the baseline 4. ALT = 1.5 × ULN within 3 months 5. BMI = 25 kg/m2 6. Signed the written informed consent form for the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Hepatobiliary diseases suspected of 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 liver disease Cirrhosis primary sclerosing cholangitis Wilson's disease a1-antitrypsin deficiency liver cancer obvious abnormal liver function (ALT or AST >= 5 x ULN or TBIL >= 1.5 x ULN) etc.; 2. Those who have a history of bariatric surgery or plan to undergo bariatric surgery in the near future; 3. Liver biopsy suggests liver cirrhosis or previous clinical diagnosis of liver cirrhosis; 4. Patients with type 1 diabetes and uncontrolled type 2 diabetes (HbA1c >= 9.5%); 5. Other clinical findings before screening show any of the following clinically significant diseases that are unstable or not treated (including but not limited to gastrointestinal tract nerve blood endocrine tumor lung immune and mental diseases); 6. Patients with a history of acute cardiovascular and cerebrovascular events: coronary angioplasty stroke; 7. Taking drugs that may cause steatosis/steatohepatitis (including amiodarone methotrexate hormones tetracycline tamoxifen steroids valproic acid etc.); 8. Taking hypoglycemic drugs GLP-1 receptor agonists (including liraglutide albiglutide dulaglutide lixisenatide semaglutide benaglutide etc.) 90 days before randomization thiazolidinedione insulin sensitizer-related drugs (including rosiglitazone pioglitazone troglitazone saiglitazone emglitazone etc.) weight loss drugs (including but not limited to sibutril orlistat) and new drugs that may improve steatohepatitis (including but not limited to obeticholic acid Elafibranor vitamin E etc.); 9. Patients who have undergone acupuncture treatment within 1 month before participating in the trial; 10. Pregnant and breastfeeding women or women who have recently had childbearing needs without contraception; 11. Patients with MRI scanning contraindications (prostheses with metal fillers tight space syndrome etc.);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the changes in relative liver fat content measured by MRI-PDFF between baseline and 12 weeks after intervention; | — |
Secondary
| Measure | Time frame |
|---|---|
| the body mass index (BMI) ; waist-hip ratio (WHR);the patients with a =30% relative decline in MRI-PDFF ;the change of liver stiffness by MRE;lipid levels (CHOL, TG, HDL-C, LDL-C);Liver and metabolic biomarkers including liver enzyme levels (ALT, AST, GGT, ALP);glucose metabolism (FBG, fasting insulin, HbAIc% and homeostatic model assessment of insulin resistance [HOMA-IR] index score);the change of MRI-PDFF(follow up 4 weeks); | — |
Countries
China
Contacts
Public ContactLi'e Xu
Beijing Friendship Hospital Capital Medical University
Outcome results
None listed