Liver Inflammation Index test for MASH in adults with T2DM and MAFLD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a national, multicenter, real-world cross-sectional study to determine how well the Liver Inflammation Index works for detecting MASH in adults with T2DM and MAFLD. It will enroll about 10,000 participants across 22 centers in China, with 9,000 in a prospective cohort and 1,000 in a retrospective cohort. Data will include demographics, medical history, lifestyle factors, standard labs, and ultrasound-based measures of steatosis and fibrosis using iLivTouch. The study aims to describe the distribution and changes of the Liver Inflammation Index in this population and assess its diagnostic accuracy when combined with imaging data.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
  Bengbu, Anhui, China Recruiting
• Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
  Wuhu, Anhui, China Recruiting
• Department of Endocrinology, Zhujiang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
  Guangzhou, Guangdong, China Recruiting
• Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Principal investigator: Yan Bi, MD,PhD — Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
• Study coordinator: Yan Bi, MD,PhD
• Email: biyan@nju.edu
• Phone: 86-25-83-105302

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.