About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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;
Trial design
Treatments tested in this trial
- iLivTouch (Vibration-controlled transient elastography)
Treatment groups
Sponsors and collaborators
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