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

2026年6月2日更新者：Yan Bi、The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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).

研究概览

地位

招聘中

条件

干预/治疗

诊断测试：iLivTouch (Vibration-controlled transient elastography)

详细说明

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).

研究类型

观察性的

注册 (估计的)

10000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Yan Bi, MD,PhD
电话号码：86-25-83-105302
邮箱：biyan@nju.edu

研究联系人备份

姓名：Jin Li, MD,PhD
电话号码：86-25-83-105302
邮箱：jinli807@126.com

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

Inclusion Criteria:

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).

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列	干预/治疗
T2DM with MAFLD	诊断测试：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.

团体/队列

干预/治疗

T2DM with MAFLD

诊断测试：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.

研究衡量的是什么？

主要结果指标

结果测量	大体时间
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population. 大体时间：Baseline	Baseline

次要结果测量

结果测量	措施说明	大体时间
Proportion of Participants with MASH Stratified by Comorbidities 大体时间：Baseline	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 大体时间：Baseline	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 大体时间：Baseline	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 大体时间：Baseline	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 大体时间：Baseline	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 大体时间：Baseline	To identify and evaluate independent demographic, clinical, and laboratory predictors (risk factors) associated with the presence of MASH using multivariable logistic regression modeling.	Baseline

其他结果措施

结果测量	措施说明	大体时间
Association Between Smoking and Alcohol Consumption Status and MASH Prevalence 大体时间：Baseline	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) 大体时间：Baseline	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