No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
10,000 (estimated)
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Other
Who this trial is looking for
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This observational study aims to evaluate a new diagnostic tool, the Liver Inflammation Index, in detecting Metabolic Dysfunction-Associated Steatohepatitis (MASH) among adults who have both Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).
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Eligibility Criteria
Inclusion Criteria:
1. Adults aged ≥18 years, with no restrictions on sex;
2. Patients clinically diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) according to the Chinese Society of Hepatology guideline Guidelines for the Prevention and Treatment of Metabolic Dysfunction…
Inclusion Criteria:
1. Adults aged ≥18 years, with no restrictions on sex;
2. Patients clinically diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) according to the Chinese Society of Hepatology guideline Guidelines for the Prevention and Treatment of Metabolic Dysfunction-Associated (Nonalcoholic) Fatty Liver Disease (2024 Edition), and additionally diagnosed with type 2 diabetes mellitus (T2DM) based on the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2024 Edition).
Exclusion Criteria:
1. Presence of unhealed wounds, scars, or other conditions in the right upper abdominal region that are unsuitable for ultrasonographic examination;
2. Development of other liver diseases during follow-up, including viral hepatitis, drug-induced liver injury, autoimmune liver disease, alcoholic liver disease, or other chronic liver diseases;
3. History of hepatic decompensation;
4. History of hepatectomy or liver transplantation;
5. History of other malignancies;
6. Presence of vascular liver disease, cystic fibrosis-associated liver disease, sarcoidosis, polycystic liver disease, congenital or rare hereditary liver diseases, mechanical cholestasis, secondary sclerosing cholangitis, or heart failure accompanied by hepatic venous congestion;
7. History of transjugular intrahepatic portosystemic shunt (TIPS);
8. Occurrence of acute hepatitis during follow-up (defined as alanine aminotransferase levels \>5 times the upper limit of normal) or acute-on-chronic liver failure (ACLF);
9. Clinical or subclinical hypothyroidism or hyperthyroidism.
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