Metabolic-associated fatty Liver disease
Conditions
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 18-70 years old (inclusive) gender is not limited; 2. Meet the western medical diagnostic criteria for MAFLD; 3. Diagnosis of MAFLD was made using magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) and MRI-PDFF was >=5%; 4. Patients agreed to enroll in this clinical study voluntarily signed an informed consent form and agreed to participate in all visits examinations and treatments according to the study protocol.
Exclusion criteria
Exclusion criteria: 1. Other causes of hepatobiliary disease suspected by history and laboratory testing including but not limited to: hepatitis B or C virus infection alcoholic liver disease drug-induced liver disease autoimmune hepatitis cirrhosis of the liver primary sclerosing cholangitis Wilson's disease al-antitrypsin deficiency and hepatocellular carcinoma (or a family history of hepatocellular carcinoma); 2. Clinical evidence suggesting the presence of cirrhosis or hepatic decompensation; 3. Severe renal insufficiency defined as blood creatinine (Scr) >=178 µmol/L or glomerular filtration rate (eGFR) = 9.5% or adjustment of glucose-lowering medication in the 2 months prior to enrollment or previous severe hypoglycemic events; 6. Comorbid thyroid disease including hyperthyroidism hypothyroidism and subclinical hypothyroidism; 7. Contraindications to MRI scanning including but not limited to: severe claustrophobia inner ear implants pacemakers or other implanted cardiac rhythm management devices intracranial aneurysm clips that are not MRI compatible any other metal non-MRI compatible implanted devices (e.g. insulin pumps marrow arthroplasties) history of intrabulbar metal debris that has not been removed and body weight or waist circumference that exceeds the functionality of the scanner; 8. Pregnant and breastfeeding women and women with the potential for pregnancy who refuse to maintain investigator-approved contraception throughout the study; 9. Participation in other clinical trials in the last 3 months; 10. Those who are unable to perform the lifestyle intervention as prescribed by their physician; 11. Any other condition that in the opinion of the investigator makes participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| magnetic resonance imaging-proton density fat fraction, MRI-PDFF; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hepatic function;Blood routine;Insulin resistance index;adipocytokine;Fasting Plasma Glucose, FPG;Body measurement indicators;Serum high sensitivity C-reactive protein;Lipid metabolism; | — |
Countries
China
Contacts
Public ContactYueqiu Gao
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed