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
調査の概要
状態
詳細な説明
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).
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Yan Bi, MD,PhD
- 電話番号：86-25-83-105302
- メール：biyan@nju.edu
研究連絡先のバックアップ
- 名前：Jin Li, MD,PhD
- 電話番号：86-25-83-105302
- メール：jinli807@126.com
研究場所
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Anhui
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Bengbu、Anhui、中国、233004
- 募集
- Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
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コンタクト：
- Xiaolei Hu
-
Hefei、Anhui、中国、230601
- 募集
- Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
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コンタクト：
- Tianrong Pan
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Wuhu、Anhui、中国、241000
- 募集
- Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
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コンタクト：
- Junfei Gu
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Guangdong
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Guangzhou、Guangdong、中国、510280
- 募集
- Department of Endocrinology, Zhujiang Hospital, Southern Medical University
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コンタクト：
- Jia Sun
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Guangzhou、Guangdong、中国、511495
- 募集
- Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
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コンタクト：
- Hui Li
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Shenzhen、Guangdong、中国、518033
- 募集
- Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
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コンタクト：
- Yunfeng Shen
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Guangxi
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Nanning、Guangxi、中国、530021
- 募集
- Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
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コンタクト：
- Yingfen Qin
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Guizhou
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Zunyi、Guizhou、中国、563000
- 募集
- Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
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コンタクト：
- Xin Liao
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Hainan
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Haikou、Hainan、中国、570311
- 募集
- Department of Endocrinology, Hainan General Hospital
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コンタクト：
- Kaining Chen
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Hennan
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Zhengzhou、Hennan、中国、450099
- 募集
- Department of Endocrinology, the First Affiliated Hospital of Henan University of CM
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コンタクト：
- Suqin Shi
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Hubei
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Wuhan、Hubei、中国、430060
- 募集
- Department of Endocrinology, Renmin Hospital of Wuhan University
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コンタクト：
- Ling Gao
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Hunan
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Hengyang、Hunan、中国、421001
- 募集
- Department of Endocrinology, the First Affiliated Hospital of University of South China
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コンタクト：
- Xinhua Xiao
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Jiangsu
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Nanjing、Jiangsu、中国、210008
- 募集
- Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
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コンタクト：
- Yan Bi, MD, PhD
- 電話番号：86-25-83-105302
- メール：biyan@nju.edu.cn
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主任研究者：
- Yan Bi, MD, PhD
-
コンタクト：
- Jin Li, MD, PhD
- 電話番号：86-25-83-105302
- メール：jinli807@126.com
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副調査官：
- Jin Li, MD, PhD
-
Suzhou、Jiangsu、中国、215006
- 募集
- Department of Endocrinology, the First Affiliated Hospital of Soochow University
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コンタクト：
- Bimin Shi, MD, PhD
- 電話番号：86-0512-65223637
- メール：shibimin@163.com
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Xuzhou、Jiangsu、中国、221009
- 募集
- Department of Endocrinology, Xuzhou Central Hospital
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コンタクト：
- Houfa Geng
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Shandong
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Qingdao、Shandong、中国、266000
- 募集
- Department of Endocrinology, the Affiliated Hospital of Qingdao University
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コンタクト：
- Yangang Wang
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Weifang、Shandong、中国、261000
- 募集
- Department of Metabolic Diseases and Weight Management, Weifang People's Hospital
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コンタクト：
- Haixia Liu
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200000
- 募集
- Department of Endocrinology, ZhongShan Hospital, Fudan University
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コンタクト：
- Xiaoying Li, MD, PhD
- 電話番号：86-21-64041990
- メール：li.xiaoying@zs-hospital.sh.cn
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Shanxi
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Xi’an、Shanxi、中国、710032
- 募集
- Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University
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コンタクト：
- Xiangyang Liu
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Yunnan
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Kunming、Yunnan、中国、650011
- 募集
- Department of Endocrinology, the Third People's Hospital of Yunnan Province
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コンタクト：
- Li Gui
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Zhejiang
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Hangzhou、Zhejiang、中国、310020
- 募集
- Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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コンタクト：
- Jiaqiang Zhou
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Wenzhou、Zhejiang、中国、325000
- 募集
- Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University
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コンタクト：
- Hong Zhu
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
T2DM with MAFLD
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.
時間枠：Baseline
|
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Participants with MASH Stratified by Comorbidities
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Association Between Smoking and Alcohol Consumption Status and MASH Prevalence
時間枠：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
|
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Correlation Between MASH Detection and Retrospective Liver-Related Events (LREs)
時間枠：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
|
協力者と研究者
協力者
捜査官
- 主任研究者：Yan Bi, MD,PhD、Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026-0142-01
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IPD 共有アクセス基準
IPD 共有サポート情報タイプ
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