Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
2 июня 2026 г. обновлено: 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).
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Подробное описание
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).
Тип исследования
Наблюдательный
Регистрация (Оцененный)
10000
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Yan Bi, MD,PhD
- Номер телефона: 86-25-83-105302
- Электронная почта: biyan@nju.edu
Учебное резервное копирование контактов
- Имя: Jin Li, MD,PhD
- Номер телефона: 86-25-83-105302
- Электронная почта: jinli807@126.com
Места учебы
-
-
Anhui
-
Bengbu, Anhui, Китай, 233004
- Рекрутинг
- Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
-
Контакт:
- Xiaolei Hu
-
Hefei, Anhui, Китай, 230601
- Рекрутинг
- Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
-
Контакт:
- Tianrong Pan
-
Wuhu, Anhui, Китай, 241000
- Рекрутинг
- Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
-
Контакт:
- Junfei Gu
-
-
Guangdong
-
Guangzhou, Guangdong, Китай, 510280
- Рекрутинг
- Department of Endocrinology, Zhujiang Hospital, Southern Medical University
-
Контакт:
- Jia Sun
-
Guangzhou, Guangdong, Китай, 511495
- Рекрутинг
- Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
-
Контакт:
- Hui Li
-
Shenzhen, Guangdong, Китай, 518033
- Рекрутинг
- Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
-
Контакт:
- Yunfeng Shen
-
-
Guangxi
-
Nanning, Guangxi, Китай, 530021
- Рекрутинг
- Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
-
Контакт:
- Yingfen Qin
-
-
Guizhou
-
Zunyi, Guizhou, Китай, 563000
- Рекрутинг
- Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
-
Контакт:
- Xin Liao
-
-
Hainan
-
Haikou, Hainan, Китай, 570311
- Рекрутинг
- Department of Endocrinology, Hainan General Hospital
-
Контакт:
- Kaining Chen
-
-
Hennan
-
Zhengzhou, Hennan, Китай, 450099
- Рекрутинг
- Department of Endocrinology, the First Affiliated Hospital of Henan University of CM
-
Контакт:
- Suqin Shi
-
-
Hubei
-
Wuhan, Hubei, Китай, 430060
- Рекрутинг
- Department of Endocrinology, Renmin Hospital of Wuhan University
-
Контакт:
- Ling Gao
-
-
Hunan
-
Hengyang, Hunan, Китай, 421001
- Рекрутинг
- Department of Endocrinology, the First Affiliated Hospital of University of South China
-
Контакт:
- Xinhua Xiao
-
-
Jiangsu
-
Nanjing, Jiangsu, Китай, 210008
- Рекрутинг
- Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
-
Контакт:
- Yan Bi, MD, PhD
- Номер телефона: 86-25-83-105302
- Электронная почта: biyan@nju.edu.cn
-
Главный следователь:
- Yan Bi, MD, PhD
-
Контакт:
- Jin Li, MD, PhD
- Номер телефона: 86-25-83-105302
- Электронная почта: jinli807@126.com
-
Младший исследователь:
- Jin Li, MD, PhD
-
Suzhou, Jiangsu, Китай, 215006
- Рекрутинг
- Department of Endocrinology, the First Affiliated Hospital of Soochow University
-
Контакт:
- Bimin Shi, MD, PhD
- Номер телефона: 86-0512-65223637
- Электронная почта: shibimin@163.com
-
Xuzhou, Jiangsu, Китай, 221009
- Рекрутинг
- Department of Endocrinology, Xuzhou Central Hospital
-
Контакт:
- Houfa Geng
-
-
Shandong
-
Qingdao, Shandong, Китай, 266000
- Рекрутинг
- Department of Endocrinology, the Affiliated Hospital of Qingdao University
-
Контакт:
- Yangang Wang
-
Weifang, Shandong, Китай, 261000
- Рекрутинг
- Department of Metabolic Diseases and Weight Management, Weifang People's Hospital
-
Контакт:
- Haixia Liu
-
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Shanghai Municipality
-
Shanghai, Shanghai Municipality, Китай, 200000
- Рекрутинг
- Department of Endocrinology, ZhongShan Hospital, Fudan University
-
Контакт:
- Xiaoying Li, MD, PhD
- Номер телефона: 86-21-64041990
- Электронная почта: li.xiaoying@zs-hospital.sh.cn
-
-
Shanxi
-
Xi’an, Shanxi, Китай, 710032
- Рекрутинг
- Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University
-
Контакт:
- Xiangyang Liu
-
-
Yunnan
-
Kunming, Yunnan, Китай, 650011
- Рекрутинг
- Department of Endocrinology, the Third People's Hospital of Yunnan Province
-
Контакт:
- Li Gui
-
-
Zhejiang
-
Hangzhou, Zhejiang, Китай, 310020
- Рекрутинг
- Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Контакт:
- Jiaqiang Zhou
-
Wenzhou, Zhejiang, Китай, 325000
- Рекрутинг
- Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University
-
Контакт:
- Hong Zhu
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Невероятностная выборка
Исследуемая популяция
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.
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.
Временное ограничение: Baseline
|
Baseline
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of Participants with MASH Stratified by Comorbidities
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Association Between Smoking and Alcohol Consumption Status and MASH Prevalence
Временное ограничение: 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)
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Соавторы
Следователи
- Главный следователь: Yan Bi, MD,PhD, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
15 мая 2026 г.
Первичное завершение (Оцененный)
31 декабря 2027 г.
Завершение исследования (Оцененный)
31 декабря 2027 г.
Даты регистрации исследования
Первый отправленный
23 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
2 июня 2026 г.
Первый опубликованный (Действительный)
8 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
8 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
2 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2026-0142-01
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
De-identified participant data may be timely shared with qualified researchers upon request, subject to review and approval.
Сроки обмена IPD
Data will become available after study completion and primary publication for 3 years.
Критерии совместного доступа к IPD
Data requests require a valid research proposal and signed data use agreement.
Approval is contingent on compliance with applicable laws and ethical guidelines.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .