Metabolic dysfunction-associated fatty liver disease
Conditions
Interventions
acupuncture group:Dietary and exercise education combined with acupuncture
sham acupuncture group:Dietary and exercise education combined with sham acupuncture
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 70 years old (inclusive), regardless of gender; 2. Meets the Western medical diagnostic criteria for MAFLD; 3. BMI>=23kg/m ^ 2; 4. Using proton density fat fraction (MRI-PDFF) derived from magnetic resonance imaging to diagnose MAFLD, liver steatosis = grade 2 (MRI-PDFF>=11%); 5. The patient agrees to participate in this clinical study, voluntarily signs an informed consent form, and agrees to participate in all visits, examinations, and treatments in accordance with the requirements of the research protocol.
Exclusion criteria
Exclusion criteria: 1. Suspected liver and gallbladder diseases with other causes through medical history and laboratory testing, including but not limited to: hepatitis B or C virus infection, alcoholic liver disease, drug-induced liver disease, autoimmune hepatitis, liver cirrhosis, primary sclerosing cholangitis, Wilson's disease, al anti pancreatic enzyme deficiency, liver cancer (or family history of liver cancer), etc; 2. Severe liver function injury, defined as alanine aminotransferase (ALT)>=2.5 times the upper limit of normal value; 3. Clinical evidence suggesting the presence of cirrhosis or decompensated liver function; 4. Severe renal insufficiency, defined as blood creatinine (Scr)>=178 µ Mol/L, or glomerular filtration rate (eGFR)=9.5%, or hypoglycemic drugs have been adjusted two months before enrollment, or serious hypoglycemic events have occurred in the past; 7. Concomitant thyroid diseases, including hyperthyroidism, hypothyroidism, and subclinical hypothyroidism; 8. There are contraindications for MRI scanning, including but not limited to: severe claustrophobia, inner ear implants, pacemakers or other implanted rhythm management devices, intracranial aneurysm clips that are incompatible with MRI, any other metal, non MRI compatible implant devices (such as insulin pumps, medullary joint replacement surgery), a history of unremoved orbital metal fragments, weight or waist circumference exceeding the scanner's function, etc; 9. Those who have received acupuncture and moxibustion treatment in the past; 10. Pregnant and lactating women, as well as women who refuse to maintain the contraceptive measures recognized by the researchers throughout the entire study process and are at risk of pregnancy; 11. Participated in other clinical trials in the past three months; 12. Those who are unable to follow medical advice for lifestyle interventions; 13. The researcher believes that there are other circumstances that are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in liver fat content measured by MRI-PDFF before and after 12 weeks of acupuncture treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Magnetic Resonance Elastography, MRE;hepatic function;lipid metabolism;homeostasis model assessment of insulin resistance;serum high sensitivity C-reactive protein;adipocytokines;body measurement indicators; | — |
Countries
China
Contacts
Public ContactYueqiu Gao
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed