metabolic dysfunction-associated steatotic liver disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Definitively diagnosed with MASLD; 2. Aged 18-70 years old; 3. Ethnic Chinese; 4. Written informed consents must be obtained.
Exclusion criteria
Exclusion criteria: 1. Participants with diabetes mellitus; 2. Participants with acute or chronic gastrointestinal diseases; 3. Participants with hyperthyroidism, hypothyroidism, chronic kidney disease, severe renal insufficiency, malignant tumor, uncontrolled hypertension or myocardial infarction or heart failure within the past six months; 4. Participants with routine use of prescription medicines or adjuvant Chinese and Western medicines (except regular contraceptives) to treat MASLD; 5. Participants using thyroid hormones, glucocorticoids and other drugs that may affect metabolism; 6. Participants using antibiotics within 3 weeks before the study or regularly using probiotics; 7. Pregnant, breastfeeding women or women planning to get pregnant; 8. Participants expected to have poor compliance; 9. Participants who have used weight-loss medication or participated in weight-loss programs in the previous 3 months; 10. Participants with mental disorders who cannot cooperate; 11. Participants with pacemaker or metallic implants, claustrophobia or other conditions that would be unable to undergo magnetic resonance examinations; 12. Participants have been enrolled in or had been enrolled in another clinical study within 4 weeks before the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in intrahepatic triglyceride content; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in anthropometric indicators;Change in body composition;Glycemic control;Change in insulin sensitivity;Change in liver and renal function;Change in lipid profiles;Change in cytokines;Multi-omics parameters;Change in intrahepatic triglyceride content (IHTC); | — |
Countries
China
Contacts
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine