Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
A Multicenter Cross-Sectional Study Evaluating the Diagnostic Accuracy of the Liver Inflammation Index for Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Patients With Concurrent Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Fatty Liver Disease
1 other identifier
observational
10,000
1 country
22
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2026
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2026
CompletedFirst Submitted
Initial submission to the registry
May 23, 2026
CompletedFirst Posted
Study publicly available on registry
June 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
June 8, 2026
June 1, 2026
1.6 years
May 23, 2026
June 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.
Baseline
Secondary Outcomes (6)
Proportion of Participants with MASH Stratified by Comorbidities
Baseline
Proportion of Participants with MASH Stratified by Hepatic Steatosis Grades
Baseline
Proportion of Participants with MASH Stratified by Liver Fibrosis Stages
Baseline
Demographic Variations in MASH Detection Rate
Baseline
Geographic Variations in MASH Detection Rate Across China
Baseline
- +1 more secondary outcomes
Other Outcomes (2)
Association Between Smoking and Alcohol Consumption Status and MASH Prevalence
Baseline
Correlation Between MASH Detection and Retrospective Liver-Related Events (LREs)
Baseline
Study Arms (1)
T2DM with MAFLD
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- 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;
- History of other malignancies;
- Presence of vascular liver disease, cystic fibrosis-associated liver disease, sarcoidosis, polycystic liver disease, congenital or rare hereditary liver diseases, mechanical cholestasis, secondary sclerosing cholangitis, or heart failure accompanied by hepatic venous congestion;
- History of transjugular intrahepatic portosystemic shunt (TIPS);
- Occurrence of acute hepatitis during follow-up (defined as alanine aminotransferase levels \>5 times the upper limit of normal) or acute-on-chronic liver failure (ACLF);
- Clinical or subclinical hypothyroidism or hyperthyroidism.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitycollaborator
- The First Affiliated Hospital of Soochow Universitycollaborator
- Xuzhou Central Hospitalcollaborator
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
- The First Affiliated Hospital of Bengbu Medical Universitycollaborator
- The Second Hospital of Anhui Medical Universitycollaborator
- The Affiliated Hospital of Qingdao Universitycollaborator
- Weifang People's Hospitalcollaborator
- Southern Medical University, Chinacollaborator
- Zunyi Medical Collegecollaborator
- Hainan General Hospitalcollaborator
- Sir Run Run Shaw Hospitalcollaborator
- Renmin Hospital of Wuhan Universitycollaborator
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schoollead
- Panyu Hospital of Traditional Chinese Medicinecollaborator
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- The Third People's Hospital of Yunnan Provincecollaborator
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicinecollaborator
- Eighth Affiliated Hospital, Sun Yat-sen Universitycollaborator
- Second Affiliated Hospital of Wannan Medical Collegecollaborator
- The First Affiliated Hospital of University of South Chinacollaborator
- The First Affiliated Hospital of Air Force Medicial Universitycollaborator
Study Sites (22)
Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004, China
Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
Wuhu, Anhui, 241000, China
Department of Endocrinology, Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 510280, China
Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 511495, China
Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, 518033, China
Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
Department of Endocrinology, Hainan General Hospital
Haikou, Hainan, 570311, China
Department of Endocrinology, the First Affiliated Hospital of Henan University of CM
Zhengzhou, Hennan, 450099, China
Department of Endocrinology, Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Department of Endocrinology, the First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001, China
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210008, China
Department of Endocrinology, the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Department of Endocrinology, Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
Department of Endocrinology, the Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Department of Metabolic Diseases and Weight Management, Weifang People's Hospital
Weifang, Shandong, 261000, China
Department of Endocrinology, ZhongShan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000, China
Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University
Xi’an, Shanxi, 710032, China
Department of Endocrinology, the Third People's Hospital of Yunnan Province
Kunming, Yunnan, 650011, China
Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310020, China
Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Bi, MD,PhD
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
May 23, 2026
First Posted
June 8, 2026
Study Start
May 15, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
June 8, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will become available after study completion and primary publication for 3 years.
- Access Criteria
- Data requests require a valid research proposal and signed data use agreement. Approval is contingent on compliance with applicable laws and ethical guidelines.
De-identified participant data may be timely shared with qualified researchers upon request, subject to review and approval.