A Multicenter Randomized Controlled Clinical Trial of Electro-acupuncture in Patients with Metabolic Associated Fatty Liver Disease

Not Applicable

• Conditions: Metabolic Associated Fatty Liver Disease

• Registration Number: ITMCTR2200006043
• Lead Sponsor: Beijing Friendship Hospital, Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female patients aged 18-65 (including 18 and 65 years old)
2. The diagnosis of MAFLD according to guidelines of the Asian Pacific Association for the Study of the Liver clinical practice
3. ALT>=1.5 X ULN twice within 3 months
4. BMI>=25 kg/m2
5. liver fat (MRI-PDFF) >=8% after run-in period
6. Sign the informed consent form.

Exclusion Criteria

1. Other concomitant liver diseases such as viral hepatitis, autoimmune liver disease, drug-induced liver disease, etc;
2.Excessive drinking for 3 months or more in the 1 year before screening (the average daily consumption of ethanol for men is more than 30 grams, which is equivalent to 3.75 units of alcohol, and for women, more than 20 grams, which is equivalent to 2.5 units of alcohol: 1 unit = 285 mL of beer, or strong 25mL wine, or 100mL wine);
3. Those who have a history of bariatric surgery or are about to undergo bariatric surgery in the near future;
4. liver cirrhosis diagnosed by histology and clinical criteria
5. Type 1 diabetes patients and uncontrolled type 2 diabetes patients (HbA1c>=9.5%);
6. Other clinical findings before screening show any clinically significant following diseases that are unstable or untreated (including but not limited to gastrointestinal tract, nerve, blood, endocrine, tumor, lung, immune, mental diseases)
7. Patients with a history of acute cardiovascular events or the following cardiovascular and cerebrovascular diseases: coronary angioplasty, stroke, transient ischemic attack, coronary heart disease;
8. Are taking drugs that may cause steatosis/steatohepatitis (including amoxicillin, methotrexate, hormones, tetracycline, tamoxifen, steroids, valproic acid, etc.);
9. 90 days before randomization, taking hypoglycemic drugs GLP-1, thiazolidinedione insulin sensitizer-related drugs, weight loss drugs (including but not limited to sibutramine, orlistat) and clinical indications may be new drugs to improve steatohepatitis (including but not limited to liraglutide, obeticholic acid, Elafibranor, vitamin E, etc.);
10. Patients who have undergone acupuncture treatment within 1 month before participating in the trial
11. Women who are pregnant or breastfeeding or who have recently had a childbirth need without contraception
12. Patients with contraindications for MRI scanning (prostheses with metal fillers, tight space syndrome, etc.);
13. Patients with a weight change of more than 5% in the 4 weeks before randomization;
14. According to the researcher's judgment, it is not suitable to participate in the research.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MRI-PDFF;

Secondary Outcome Measures

Name	Time	Method
MRE;blood cholesterol;blood triglycerides;Weight;Insulin resistance index(HOMA-IR);blood low-density lipoprotein;waistline;blood glucose;hip circumference;