Study of the Liver Inflammation Index to Detect Metabolic Dysfunction-Associated Steatohepatitis in Adults With Type 2 Diabetes and Fatty Liver Disease

What this Trial Is About

Researchers are evaluating the Liver Inflammation Index as a new diagnostic tool to detect Metabolic Dysfunction-Associated Steatohepatitis MASH in adults who have both Type 2 Diabetes Mellitus T2DM and Metabolic Dysfunction-Associated Fatty Liver Disease MAFLD. This observational, multicenter, real-world study will collect data from 10,000 participants across 22 research centers in China, aiming to assess the clinical usefulness and accuracy of this index in identifying MASH. Participants will undergo non-invasive diagnostic testing with the iLivTouch device, which measures the Liver Inflammation Index, Ultrasound Attenuation Parameter UAP for liver fat grading, and Liver Stiffness Measurement LSM for fibrosis staging. Data collection includes comprehensive clinical information, medical history, physical exams, lifestyle questionnaires, and standard lab tests. The study includes both a large prospective cohort and a smaller retrospective cohort. During the study, researchers will gather detailed participant information including demographics, comorbid conditions, lifestyle factors, and clinical test results. They will analyze the detection rates of MASH and explore how these rates vary by liver condition severity, comorbidities, and demographics. The study also looks at the impact of lifestyle factors on MASH and will review liver-related events over a five-year period where data is available. The main outcome is the detection rate of MASH at baseline among this patient group.

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