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Based on the oral-gut-liver axis, the effect mechanism of mid-day flow injection at ear points in the treatment of metabolism-related fatty liver disease was investigated

Based on the oral-gut-liver axis, the effect mechanism of mid-day flow injection at ear points in the treatment of metabolism-related fatty liver disease was investigated

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082157
Enrollment
Unknown
Registered
2024-03-22
Start date
2024-04-08
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolically associated fatty liver disease

Interventions

treatment group:Midafternoon flow injection of ear points with lifestyle (improve diet structure, increase exercise time) intervention treatment for 8 weeks
control group:The patients were treated with lifestyle intervention (improved diet and increased exercise time) for 8 weeks

Sponsors

Wuxi Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Those who met the diagnostic criteria for metabolically related fatty liver disease: The diagnostic criteria for MAFLD were based on histological (liver biopsy), imaging, and blood biomarker evidence of hepatic fat accumulation (hepatocellular steatosis) combined with one of the following three conditions: overweight/obesity, type 2 diabetes, and metabolic dysfunction. 2. Age 18-65 years old; 3. Ultrasound indicated that the fat content was > 30%; BMI <35 kg/m2; 4. Be willing and able to follow predetermined visit plans, diet and exercise instructions, laboratory tests, and other research procedures. 5. Serum alanine aminotransferase (ALT) is less than or equal to 2 times the normal upper limit;

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Patients who used other liver protection and enzyme lowering drugs in the past 1 month and affected the efficacy evaluation; 2. Patients who took tamoxifen, ethamiodarone, sodium valproate, methotrexate, glucocorticoid and other drugs in the past 3 months to affect lipid metabolism; 3. Special cases of fatty liver caused by total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, ß-lipoprotein deficiency, lipid atrophic diabetes, Mauriac syndrome, etc.; 4. Alcoholic fatty liver (alcohol intake >30g/d for men, alcohol intake >20g/d for women), cirrhosis, hepatitis B, hepatitis C and other liver diseases, autoimmune liver disease, or liver decompensation; 5. Patients with type 2 diabetes with unstable control (HbA1c=9.5% within 1 month before enrollment); 6. High or very high risk of extensive atherosclerotic diseases; 7. Patients who have had gastrointestinal bariatric surgery in the past year or who have taken weight-loss drugs in the past three months have lost more than 10% of their body weight; 8. Drug or narcotic drug abuse history; 9. Pregnant and lactating women and cardiovascular, lung, kidney, hematopoietic system and other major primary diseases.

Design outcomes

Primary

MeasureTime frame
Fecal genome sequencing;Genome sequencing of tongue coating samples;Liver function;Blood fat;Fasting blood-glucose;Liver, bile, pancreas and spleen ultrasound;Body Mass Index;

Secondary

MeasureTime frame
SF-36 Quality of Life Questionnaire;Information collection of TCM physique scale;

Countries

China

Contacts

Public ContactRunfei Sun

Wuxi Second People's Hospital

xwzjtcm@outlook.com+86 150 6180 1787

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026