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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

10,000 Participants
are divided into 1 treatment group

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