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

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).

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM); Metabolic Dysfunction-associated Fatty Liver Disease; MASH - Metabolic Dysfunction-Associated Steatohepatitis
• Intervention / Treatment: Diagnostic test: iLivTouch (Vibration-controlled transient elastography)

Detailed Description

This study is a national, multicenter, real-world, cross-sectional observational trial designed to assess the clinical utility and diagnostic accuracy of the Liver Inflammation Index for identifying Metabolic Dysfunction-Associated Steatohepatitis (MASH) in patients with concurrent Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

The study plans to enroll a total of 10,000 participants across 22 major research centers in China. Data collection will be split into a prospective cohort (9,000 patients) and a retrospective cohort (1,000 patients). Each participating center will enroll between 100 and 2,000 subjects.

Study Procedures and Data Collection:

For all eligible participants, researchers will systematically collect comprehensive clinical data. This includes general demographic information, detailed past medical history, physical examination findings, and lifestyle questionnaires (assessing diet, physical activity, smoking, and alcohol consumption). Clinical assessments will involve standard laboratory tests to calculate the Liver Inflammation Index. Additionally, participants will undergo vibration-controlled transient elastography (using the iLivTouch device) to obtain the Ultrasound Attenuation Parameter (UAP) for steatosis grading and Liver Stiffness Measurement (LSM) for fibrosis staging.

Study Objectives:

The primary objective is to investigate the distribution and alterations of the Liver Inflammation Index in the Chinese T2DM and MAFLD population, and to evaluate the overall detection rate of MASH within this cohort.

Secondary objectives focus on stratifying the MASH detection rate based on several clinical variables:

The presence of comorbidities (including cardiovascular disease, chronic kidney disease, obesity, dyslipidemia, and hypertension).

The degree of hepatic steatosis (S1, S2, and S3), as determined by UAP results.

The severity of liver fibrosis (F0-F1, F2, F3, and F4), as determined by LSM results.

Demographic stratifications, including age, gender, and geographic region within China.

Identification of predictive risk factors associated with MASH in this specific patient population.

Exploratory Endpoints:

The study will explore the impact of modifiable, adverse lifestyle factors on the prevalence of MASH. Furthermore, a 5-year retrospective data collection (where hospital records permit) will be conducted to analyze the relationship between the MASH detection rate and various Liver-Related Events (LREs). 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 (including ascites, overt hepatic encephalopathy, bacterial infections, and non-obstructive jaundice).

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Yan Bi, MD,PhD; Phone Number: 86-25-83-105302; Email: biyan@nju.edu
• Study Contact Backup: Name: Jin Li, MD,PhD; Phone Number: 86-25-83-105302; Email: jinli807@126.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Recruiting
      • Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
      • Contact: Xiaolei Hu
    • Hefei, Anhui, China, 230601
      • Recruiting
      • Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
      • Contact: Tianrong Pan
    • Wuhu, Anhui, China, 241000
      • Recruiting
      • Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
      • Contact: Junfei Gu
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Recruiting
      • Department of Endocrinology, Zhujiang Hospital, Southern Medical University
      • Contact: Jia Sun
    • Guangzhou, Guangdong, China, 511495
      • Recruiting
      • Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
      • Contact: Hui Li
    • Shenzhen, Guangdong, China, 518033
      • Recruiting
      • Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
      • Contact: Yunfeng Shen
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
      • Contact: Yingfen Qin
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Recruiting
      • Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
      • Contact: Xin Liao
  • Hainan
    • Haikou, Hainan, China, 570311
      • Recruiting
      • Department of Endocrinology, Hainan General Hospital
      • Contact: Kaining Chen
  • Hennan
    • Zhengzhou, Hennan, China, 450099
      • Recruiting
      • Department of Endocrinology, the First Affiliated Hospital of Henan University of CM
      • Contact: Suqin Shi
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Department of Endocrinology, Renmin Hospital of Wuhan University
      • Contact: Ling Gao
  • Hunan
    • Hengyang, Hunan, China, 421001
      • Recruiting
      • Department of Endocrinology, the First Affiliated Hospital of University of South China
      • Contact: Xinhua Xiao
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
      • Contact: Yan Bi, MD, PhD; Phone Number: 86-25-83-105302; Email: biyan@nju.edu.cn
      • Principal Investigator: Yan Bi, MD, PhD
      • Contact: Jin Li, MD, PhD; Phone Number: 86-25-83-105302; Email: jinli807@126.com
      • Sub-Investigator: Jin Li, MD, PhD
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • Department of Endocrinology, the First Affiliated Hospital of Soochow University
      • Contact: Bimin Shi, MD, PhD; Phone Number: 86-0512-65223637; Email: shibimin@163.com
    • Xuzhou, Jiangsu, China, 221009
      • Recruiting
      • Department of Endocrinology, Xuzhou Central Hospital
      • Contact: Houfa Geng
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • Department of Endocrinology, the Affiliated Hospital of Qingdao University
      • Contact: Yangang Wang
    • Weifang, Shandong, China, 261000
      • Recruiting
      • Department of Metabolic Diseases and Weight Management, Weifang People's Hospital
      • Contact: Haixia Liu
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Recruiting
      • Department of Endocrinology, ZhongShan Hospital, Fudan University
      • Contact: Xiaoying Li, MD, PhD; Phone Number: 86-21-64041990; Email: li.xiaoying@zs-hospital.sh.cn
  • Shanxi
    • Xi’an, Shanxi, China, 710032
      • Recruiting
      • Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University
      • Contact: Xiangyang Liu
  • Yunnan
    • Kunming, Yunnan, China, 650011
      • Recruiting
      • Department of Endocrinology, the Third People's Hospital of Yunnan Province
      • Contact: Li Gui
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310020
      • Recruiting
      • Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Contact: Jiaqiang Zhou
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University
      • Contact: Hong Zhu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Adults aged ≥18 years, with no restrictions on sex;
2. 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).

Exclusion Criteria:

1. Presence of unhealed wounds, scars, or other conditions in the right upper abdominal region that are unsuitable for ultrasonographic examination;
2. 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;
3. History of hepatic decompensation;
4. History of hepatectomy or liver transplantation;
5. History of other malignancies;
6. 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;
7. History of transjugular intrahepatic portosystemic shunt (TIPS);
8. 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);
9. Clinical or subclinical hypothyroidism or hyperthyroidism.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

T2DM with MAFLD

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
Geographic Variations in MASH Detection Rate Across China	To evaluate the regional differences in the detection rate of MASH among the enrolled cohort of T2DM and MAFLD patients across different geographical regions within China.	Baseline
Identification of Risk Factors Associated with MASH	To identify and evaluate independent demographic, clinical, and laboratory predictors (risk factors) associated with the presence of MASH using multivariable logistic regression modeling.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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).	Baseline

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Collaborators: Fudan University; The Affiliated Hospital of Qingdao University; The First Affiliated Hospital of Soochow University; Xuzhou Central Hospital; Renmin Hospital of Wuhan University; The First Affiliated Hospital of University of South China; The First Affiliated Hospital of Henan University of Traditional Chinese Medicine; Sir Run Run Shaw Hospital; Hainan General Hospital; First Affiliated Hospital of Wenzhou Medical University; Southern Medical University, China; The Second Hospital of Anhui Medical University; Zunyi Medical College; First Affiliated Hospital of Guangxi Medical University; Weifang People's Hospital; Eighth Affiliated Hospital, Sun Yat-sen University; Panyu Hospital of Traditional Chinese Medicine; The First Affiliated Hospital of Air Force Medicial University; The Third People's Hospital of Yunnan Province; The First Affiliated Hospital of Bengbu Medical University; Second Affiliated Hospital of Wannan Medical College
• Investigators: Principal Investigator: Yan Bi, MD,PhD, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 23, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; MAFLD; MASH; Liver inflammation index
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2026-0142-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data may be timely shared with qualified researchers upon request, subject to review and approval.
• IPD Sharing Time Frame: Data will become available after study completion and primary publication for 3 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No