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

Summary

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).

Conditions

• Type 2 Diabetes Mellitus (T2DM)
• MASH - Metabolic Dysfunction-Associated Steatohepatitis
• Metabolic Dysfunction-associated Fatty Liver Disease

Interventions

DIAGNOSTIC_TEST

iLivTouch (Vibration-controlled transient elastography)

A 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.

Sponsors & Collaborators

• Fudan University

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• Xuzhou Central Hospital

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• The First Affiliated Hospital of Bengbu Medical University

  collaborator OTHER

• The Second Hospital of Anhui Medical University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Weifang People's Hospital

  collaborator OTHER

• Panyu Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Zunyi Medical College

  collaborator OTHER

• The First Affiliated Hospital of Air Force Medicial University

  collaborator OTHER

• Hainan General Hospital

  collaborator OTHER

• The Third People's Hospital of Yunnan Province

  collaborator OTHER_GOV

• Sir Run Run Shaw Hospital

  collaborator OTHER

• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  collaborator OTHER

• Eighth Affiliated Hospital, Sun Yat-sen University

  collaborator OTHER

• Second Affiliated Hospital of Wannan Medical College

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• The First Affiliated Hospital of University of South China

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  lead OTHER

Principal Investigators

• Yan Bi, MD,PhD · Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-15

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• China

Study Locations