Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
2 juin 2026 mis à jour par: 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).
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Observationnel
Inscription (Estimé)
10000
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Yan Bi, MD,PhD
- Numéro de téléphone: 86-25-83-105302
- E-mail: biyan@nju.edu
Sauvegarde des contacts de l'étude
- Nom: Jin Li, MD,PhD
- Numéro de téléphone: 86-25-83-105302
- E-mail: jinli807@126.com
Lieux d'étude
-
-
Anhui
-
Bengbu, Anhui, Chine, 233004
- Recrutement
- Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
-
Contact:
- Xiaolei Hu
-
Hefei, Anhui, Chine, 230601
- Recrutement
- Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
-
Contact:
- Tianrong Pan
-
Wuhu, Anhui, Chine, 241000
- Recrutement
- Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
-
Contact:
- Junfei Gu
-
-
Guangdong
-
Guangzhou, Guangdong, Chine, 510280
- Recrutement
- Department of Endocrinology, Zhujiang Hospital, Southern Medical University
-
Contact:
- Jia Sun
-
Guangzhou, Guangdong, Chine, 511495
- Recrutement
- Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
-
Contact:
- Hui Li
-
Shenzhen, Guangdong, Chine, 518033
- Recrutement
- Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
-
Contact:
- Yunfeng Shen
-
-
Guangxi
-
Nanning, Guangxi, Chine, 530021
- Recrutement
- Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
-
Contact:
- Yingfen Qin
-
-
Guizhou
-
Zunyi, Guizhou, Chine, 563000
- Recrutement
- Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
-
Contact:
- Xin Liao
-
-
Hainan
-
Haikou, Hainan, Chine, 570311
- Recrutement
- Department of Endocrinology, Hainan General Hospital
-
Contact:
- Kaining Chen
-
-
Hennan
-
Zhengzhou, Hennan, Chine, 450099
- Recrutement
- Department of Endocrinology, the First Affiliated Hospital of Henan University of CM
-
Contact:
- Suqin Shi
-
-
Hubei
-
Wuhan, Hubei, Chine, 430060
- Recrutement
- Department of Endocrinology, Renmin Hospital of Wuhan University
-
Contact:
- Ling Gao
-
-
Hunan
-
Hengyang, Hunan, Chine, 421001
- Recrutement
- Department of Endocrinology, the First Affiliated Hospital of University of South China
-
Contact:
- Xinhua Xiao
-
-
Jiangsu
-
Nanjing, Jiangsu, Chine, 210008
- Recrutement
- 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
- Numéro de téléphone: 86-25-83-105302
- E-mail: biyan@nju.edu.cn
-
Chercheur principal:
- Yan Bi, MD, PhD
-
Contact:
- Jin Li, MD, PhD
- Numéro de téléphone: 86-25-83-105302
- E-mail: jinli807@126.com
-
Sous-enquêteur:
- Jin Li, MD, PhD
-
Suzhou, Jiangsu, Chine, 215006
- Recrutement
- Department of Endocrinology, the First Affiliated Hospital of Soochow University
-
Contact:
- Bimin Shi, MD, PhD
- Numéro de téléphone: 86-0512-65223637
- E-mail: shibimin@163.com
-
Xuzhou, Jiangsu, Chine, 221009
- Recrutement
- Department of Endocrinology, Xuzhou Central Hospital
-
Contact:
- Houfa Geng
-
-
Shandong
-
Qingdao, Shandong, Chine, 266000
- Recrutement
- Department of Endocrinology, the Affiliated Hospital of Qingdao University
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Contact:
- Yangang Wang
-
Weifang, Shandong, Chine, 261000
- Recrutement
- Department of Metabolic Diseases and Weight Management, Weifang People's Hospital
-
Contact:
- Haixia Liu
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200000
- Recrutement
- Department of Endocrinology, ZhongShan Hospital, Fudan University
-
Contact:
- Xiaoying Li, MD, PhD
- Numéro de téléphone: 86-21-64041990
- E-mail: li.xiaoying@zs-hospital.sh.cn
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-
Shanxi
-
Xi’an, Shanxi, Chine, 710032
- Recrutement
- Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University
-
Contact:
- Xiangyang Liu
-
-
Yunnan
-
Kunming, Yunnan, Chine, 650011
- Recrutement
- Department of Endocrinology, the Third People's Hospital of Yunnan Province
-
Contact:
- Li Gui
-
-
Zhejiang
-
Hangzhou, Zhejiang, Chine, 310020
- Recrutement
- Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Contact:
- Jiaqiang Zhou
-
Wenzhou, Zhejiang, Chine, 325000
- Recrutement
- Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University
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Contact:
- Hong Zhu
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.
Délai: Baseline
|
Baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of Participants with MASH Stratified by Comorbidities
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Association Between Smoking and Alcohol Consumption Status and MASH Prevalence
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Yan Bi, MD,PhD, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
15 mai 2026
Achèvement primaire (Estimé)
31 décembre 2027
Achèvement de l'étude (Estimé)
31 décembre 2027
Dates d'inscription aux études
Première soumission
23 mai 2026
Première soumission répondant aux critères de contrôle qualité
2 juin 2026
Première publication (Réel)
8 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-0142-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified participant data may be timely shared with qualified researchers upon request, subject to review and approval.
Délai de partage IPD
Data will become available after study completion and primary publication for 3 years.
Critères d'accès au partage IPD
Data requests require a valid research proposal and signed data use agreement.
Approval is contingent on compliance with applicable laws and ethical guidelines.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .