Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
2 de junio de 2026 actualizado por: 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).
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
De observación
Inscripción (Estimado)
10000
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yan Bi, MD,PhD
- Número de teléfono: 86-25-83-105302
- Correo electrónico: biyan@nju.edu
Copia de seguridad de contactos de estudio
- Nombre: Jin Li, MD,PhD
- Número de teléfono: 86-25-83-105302
- Correo electrónico: jinli807@126.com
Ubicaciones de estudio
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Anhui
-
Bengbu, Anhui, Porcelana, 233004
- Reclutamiento
- Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
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Contacto:
- Xiaolei Hu
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Hefei, Anhui, Porcelana, 230601
- Reclutamiento
- Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
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Contacto:
- Tianrong Pan
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Wuhu, Anhui, Porcelana, 241000
- Reclutamiento
- Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
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Contacto:
- Junfei Gu
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510280
- Reclutamiento
- Department of Endocrinology, Zhujiang Hospital, Southern Medical University
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Contacto:
- Jia Sun
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Guangzhou, Guangdong, Porcelana, 511495
- Reclutamiento
- Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
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Contacto:
- Hui Li
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Shenzhen, Guangdong, Porcelana, 518033
- Reclutamiento
- Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
-
Contacto:
- Yunfeng Shen
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Guangxi
-
Nanning, Guangxi, Porcelana, 530021
- Reclutamiento
- Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
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Contacto:
- Yingfen Qin
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Guizhou
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Zunyi, Guizhou, Porcelana, 563000
- Reclutamiento
- Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
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Contacto:
- Xin Liao
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Hainan
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Haikou, Hainan, Porcelana, 570311
- Reclutamiento
- Department of Endocrinology, Hainan General Hospital
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Contacto:
- Kaining Chen
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Hennan
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Zhengzhou, Hennan, Porcelana, 450099
- Reclutamiento
- Department of Endocrinology, the First Affiliated Hospital of Henan University of CM
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Contacto:
- Suqin Shi
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Hubei
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Wuhan, Hubei, Porcelana, 430060
- Reclutamiento
- Department of Endocrinology, Renmin Hospital of Wuhan University
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Contacto:
- Ling Gao
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Hunan
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Hengyang, Hunan, Porcelana, 421001
- Reclutamiento
- Department of Endocrinology, the First Affiliated Hospital of University of South China
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Contacto:
- Xinhua Xiao
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210008
- Reclutamiento
- Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
-
Contacto:
- Yan Bi, MD, PhD
- Número de teléfono: 86-25-83-105302
- Correo electrónico: biyan@nju.edu.cn
-
Investigador principal:
- Yan Bi, MD, PhD
-
Contacto:
- Jin Li, MD, PhD
- Número de teléfono: 86-25-83-105302
- Correo electrónico: jinli807@126.com
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Sub-Investigador:
- Jin Li, MD, PhD
-
Suzhou, Jiangsu, Porcelana, 215006
- Reclutamiento
- Department of Endocrinology, the First Affiliated Hospital of Soochow University
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Contacto:
- Bimin Shi, MD, PhD
- Número de teléfono: 86-0512-65223637
- Correo electrónico: shibimin@163.com
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Xuzhou, Jiangsu, Porcelana, 221009
- Reclutamiento
- Department of Endocrinology, Xuzhou Central Hospital
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Contacto:
- Houfa Geng
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Shandong
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Qingdao, Shandong, Porcelana, 266000
- Reclutamiento
- Department of Endocrinology, the Affiliated Hospital of Qingdao University
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Contacto:
- Yangang Wang
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Weifang, Shandong, Porcelana, 261000
- Reclutamiento
- Department of Metabolic Diseases and Weight Management, Weifang People's Hospital
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Contacto:
- Haixia Liu
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200000
- Reclutamiento
- Department of Endocrinology, ZhongShan Hospital, Fudan University
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Contacto:
- Xiaoying Li, MD, PhD
- Número de teléfono: 86-21-64041990
- Correo electrónico: li.xiaoying@zs-hospital.sh.cn
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Shanxi
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Xi’an, Shanxi, Porcelana, 710032
- Reclutamiento
- Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University
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Contacto:
- Xiangyang Liu
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Yunnan
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Kunming, Yunnan, Porcelana, 650011
- Reclutamiento
- Department of Endocrinology, the Third People's Hospital of Yunnan Province
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Contacto:
- Li Gui
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310020
- Reclutamiento
- Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Contacto:
- Jiaqiang Zhou
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Wenzhou, Zhejiang, Porcelana, 325000
- Reclutamiento
- Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University
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Contacto:
- Hong Zhu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.
Periodo de tiempo: Baseline
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of Participants with MASH Stratified by Comorbidities
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Association Between Smoking and Alcohol Consumption Status and MASH Prevalence
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Yan Bi, MD,PhD, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de mayo de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
23 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de junio de 2026
Publicado por primera vez (Actual)
8 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-0142-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified participant data may be timely shared with qualified researchers upon request, subject to review and approval.
Marco de tiempo para compartir IPD
Data will become available after study completion and primary publication for 3 years.
Criterios de acceso compartido de IPD
Data requests require a valid research proposal and signed data use agreement.
Approval is contingent on compliance with applicable laws and ethical guidelines.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .