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Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD

RECRUITINGSponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Actively Recruiting
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Started2026-05-15
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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).

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions5

DiabetesLiver DiseaseMASH - Metabolic Dysfunction-Associated SteatohepatitisMetabolic Dysfunction-associated Fatty Liver DiseaseType 2 Diabetes Mellitus (T2DM)

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