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).
Adults aged ≥18 years, with no restrictions on sex;
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).
Presence of unhealed wounds, scars, or other conditions in the right upper abdominal region that are unsuitable for ultrasonographic examination;
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;
History of hepatic decompensation;
History of hepatectomy or liver transplantation;
The study population consists of adult patients concurrently diagnosed with Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD). Participants will be continuously enrolled from both outpatient clinics and inpatient departments across 22 major research centers and tertiary hospitals located in various geographic regions of China. This cohort represents a real-world clinical population seeking routine medical care, health evaluations, or regular follow-ups for their metabolic and endocrine conditions. Data will be collected through both prospective clinical assessments and retrospective medical record reviews.
Cohort
Cross-sectional
iLivTouch (Vibration-controlled transient elastography)
Diagnostic testA non-invasive diagnostic assessment performed using the iLivTouch device. This device simultaneously generates three key metrics: the Liver Inflammation Index (the primary target evaluated for its accuracy in detecting MASH), the Ultrasound Attenuation Parameter (UAP) for hepatic steatosis grading, and the Liver Stiffness Measurement (LSM) for fibrosis staging.
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.
Proportion of Participants with MASH Stratified by Comorbidities
To evaluate and compare the detection rate of Metabolic Dysfunction-Associated Steatohepatitis (MASH) among subgroups of patients with specific concurrent conditions, including cardiovascular disease, chronic kidney disease, obesity, dyslipidemia, and hypertension.
Proportion of Participants with MASH Stratified by Hepatic Steatosis Grades
To analyze the differences in the detection rate of MASH across varying degrees of hepatic steatosis (mild \[S1\], moderate \[S2\], and severe \[S3\]), as determined by the Ultrasound Attenuation Parameter (UAP) via transient elastography.
Proportion of Participants with MASH Stratified by Liver Fibrosis Stages
To assess the differences in the detection rate of MASH among patients with different stages of liver fibrosis (F0-F1, F2, F3, and F4), as classified by Liver Stiffness Measurement (LSM) via transient elastography.
Demographic Variations in MASH Detection Rate
To determine the detection rate of MASH stratified by key demographic factors, specifically gender and predefined age groups, to identify potential population-specific distribution patterns.
Association Between Smoking and Alcohol Consumption Status and MASH Prevalence
Smoking status and alcohol consumption status will be collected at baseline and recorded as binary variables (Yes/No). The association between smoking status, alcohol consumption status, and the prevalence of MASH will be evaluated.
Correlation Between MASH Detection and Retrospective Liver-Related Events (LREs)
To analyze the relationship between the current presence of MASH and a history of Liver-Related Events (LREs) by collecting retrospective patient data (where hospital records permit). LREs are defined as the occurrence of any of the following: Model for End-Stage Liver Disease (MELD) score ≥ 15, liver-related mortality, liver transplantation, progression to hepatocellular carcinoma, esophagogastric variceal bleeding, or hepatic decompensation (such as ascites, overt hepatic encephalopathy, or bacterial infections).
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
Fudan University
Collaborator
The First Affiliated Hospital of Soochow University
Collaborator
Xuzhou Central Hospital
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
The First Affiliated Hospital of Bengbu Medical University
Collaborator
The Second Hospital of Anhui Medical University
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Weifang People's Hospital
Collaborator
Panyu Hospital of Traditional Chinese Medicine
Collaborator
Southern Medical University, China
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
Zunyi Medical College
Collaborator
The First Affiliated Hospital of Air Force Medicial University
Collaborator
Hainan General Hospital
Collaborator
The Third People's Hospital of Yunnan Province
Collaborator
Sir Run Run Shaw Hospital
Collaborator
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Collaborator
Eighth Affiliated Hospital, Sun Yat-sen University
Collaborator
Second Affiliated Hospital of Wannan Medical College
Collaborator
Renmin Hospital of Wuhan University
Collaborator
The First Affiliated Hospital of University of South China
Collaborator
