Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
2026년 6월 2일 업데이트: 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).
연구 개요
상태
모병
상세 설명
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).
연구 유형
관찰
등록 (추정된)
10000
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yan Bi, MD,PhD
- 전화번호: 86-25-83-105302
- 이메일: biyan@nju.edu
연구 연락처 백업
- 이름: Jin Li, MD,PhD
- 전화번호: 86-25-83-105302
- 이메일: jinli807@126.com
연구 장소
-
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Anhui
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Bengbu, Anhui, 중국, 233004
- 모병
- Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
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연락하다:
- Xiaolei Hu
-
Hefei, Anhui, 중국, 230601
- 모병
- Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
-
연락하다:
- Tianrong Pan
-
Wuhu, Anhui, 중국, 241000
- 모병
- Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
-
연락하다:
- Junfei Gu
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510280
- 모병
- Department of Endocrinology, Zhujiang Hospital, Southern Medical University
-
연락하다:
- Jia Sun
-
Guangzhou, Guangdong, 중국, 511495
- 모병
- Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
-
연락하다:
- Hui Li
-
Shenzhen, Guangdong, 중국, 518033
- 모병
- Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
-
연락하다:
- Yunfeng Shen
-
-
Guangxi
-
Nanning, Guangxi, 중국, 530021
- 모병
- Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
-
연락하다:
- Yingfen Qin
-
-
Guizhou
-
Zunyi, Guizhou, 중국, 563000
- 모병
- Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
-
연락하다:
- Xin Liao
-
-
Hainan
-
Haikou, Hainan, 중국, 570311
- 모병
- Department of Endocrinology, Hainan General Hospital
-
연락하다:
- Kaining Chen
-
-
Hennan
-
Zhengzhou, Hennan, 중국, 450099
- 모병
- Department of Endocrinology, the First Affiliated Hospital of Henan University of CM
-
연락하다:
- Suqin Shi
-
-
Hubei
-
Wuhan, Hubei, 중국, 430060
- 모병
- Department of Endocrinology, Renmin Hospital of Wuhan University
-
연락하다:
- Ling Gao
-
-
Hunan
-
Hengyang, Hunan, 중국, 421001
- 모병
- Department of Endocrinology, the First Affiliated Hospital of University of South China
-
연락하다:
- Xinhua Xiao
-
-
Jiangsu
-
Nanjing, Jiangsu, 중국, 210008
- 모병
- Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
-
연락하다:
- Yan Bi, MD, PhD
- 전화번호: 86-25-83-105302
- 이메일: biyan@nju.edu.cn
-
수석 연구원:
- Yan Bi, MD, PhD
-
연락하다:
- Jin Li, MD, PhD
- 전화번호: 86-25-83-105302
- 이메일: jinli807@126.com
-
부수사관:
- Jin Li, MD, PhD
-
Suzhou, Jiangsu, 중국, 215006
- 모병
- Department of Endocrinology, the First Affiliated Hospital of Soochow University
-
연락하다:
- Bimin Shi, MD, PhD
- 전화번호: 86-0512-65223637
- 이메일: shibimin@163.com
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Xuzhou, Jiangsu, 중국, 221009
- 모병
- Department of Endocrinology, Xuzhou Central Hospital
-
연락하다:
- Houfa Geng
-
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Shandong
-
Qingdao, Shandong, 중국, 266000
- 모병
- Department of Endocrinology, the Affiliated Hospital of Qingdao University
-
연락하다:
- Yangang Wang
-
Weifang, Shandong, 중국, 261000
- 모병
- Department of Metabolic Diseases and Weight Management, Weifang People's Hospital
-
연락하다:
- Haixia Liu
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, 중국, 200000
- 모병
- Department of Endocrinology, ZhongShan Hospital, Fudan University
-
연락하다:
- Xiaoying Li, MD, PhD
- 전화번호: 86-21-64041990
- 이메일: li.xiaoying@zs-hospital.sh.cn
-
-
Shanxi
-
Xi’an, Shanxi, 중국, 710032
- 모병
- Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University
-
연락하다:
- Xiangyang Liu
-
-
Yunnan
-
Kunming, Yunnan, 중국, 650011
- 모병
- Department of Endocrinology, the Third People's Hospital of Yunnan Province
-
연락하다:
- Li Gui
-
-
Zhejiang
-
Hangzhou, Zhejiang, 중국, 310020
- 모병
- Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
연락하다:
- Jiaqiang Zhou
-
Wenzhou, Zhejiang, 중국, 325000
- 모병
- Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University
-
연락하다:
- Hong Zhu
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.
기간: Baseline
|
Baseline
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of Participants with MASH Stratified by Comorbidities
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Association Between Smoking and Alcohol Consumption Status and MASH Prevalence
기간: 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)
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Yan Bi, MD,PhD, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 15일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 5월 23일
QC 기준을 충족하는 최초 제출
2026년 6월 2일
처음 게시됨 (실제)
2026년 6월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 2일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2026-0142-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
De-identified participant data may be timely shared with qualified researchers upon request, subject to review and approval.
IPD 공유 기간
Data will become available after study completion and primary publication for 3 years.
IPD 공유 액세스 기준
Data requests require a valid research proposal and signed data use agreement.
Approval is contingent on compliance with applicable laws and ethical guidelines.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Jordi Gol i Gurina FoundationFundació Institut Germans Trias i Pujol; Institut d'Investigacions Biomèdiques August Pi... 그리고 다른 협력자들아직 모집하지 않음
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IRCCS Azienda Ospedaliero-Universitaria di Bologna알려지지 않은