Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
2. juni 2026 oppdatert av: 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).
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Observasjonsmessig
Registrering (Antatt)
10000
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yan Bi, MD,PhD
- Telefonnummer: 86-25-83-105302
- E-post: biyan@nju.edu
Studer Kontakt Backup
- Navn: Jin Li, MD,PhD
- Telefonnummer: 86-25-83-105302
- E-post: jinli807@126.com
Studiesteder
-
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Anhui
-
Bengbu, Anhui, Kina, 233004
- Rekruttering
- Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
-
Ta kontakt med:
- Xiaolei Hu
-
Hefei, Anhui, Kina, 230601
- Rekruttering
- Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
-
Ta kontakt med:
- Tianrong Pan
-
Wuhu, Anhui, Kina, 241000
- Rekruttering
- Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
-
Ta kontakt med:
- Junfei Gu
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510280
- Rekruttering
- Department of Endocrinology, Zhujiang Hospital, Southern Medical University
-
Ta kontakt med:
- Jia Sun
-
Guangzhou, Guangdong, Kina, 511495
- Rekruttering
- Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
-
Ta kontakt med:
- Hui Li
-
Shenzhen, Guangdong, Kina, 518033
- Rekruttering
- Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
-
Ta kontakt med:
- Yunfeng Shen
-
-
Guangxi
-
Nanning, Guangxi, Kina, 530021
- Rekruttering
- Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
-
Ta kontakt med:
- Yingfen Qin
-
-
Guizhou
-
Zunyi, Guizhou, Kina, 563000
- Rekruttering
- Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
-
Ta kontakt med:
- Xin Liao
-
-
Hainan
-
Haikou, Hainan, Kina, 570311
- Rekruttering
- Department of Endocrinology, Hainan General Hospital
-
Ta kontakt med:
- Kaining Chen
-
-
Hennan
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Zhengzhou, Hennan, Kina, 450099
- Rekruttering
- Department of Endocrinology, the First Affiliated Hospital of Henan University of CM
-
Ta kontakt med:
- Suqin Shi
-
-
Hubei
-
Wuhan, Hubei, Kina, 430060
- Rekruttering
- Department of Endocrinology, Renmin Hospital of Wuhan University
-
Ta kontakt med:
- Ling Gao
-
-
Hunan
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Hengyang, Hunan, Kina, 421001
- Rekruttering
- Department of Endocrinology, the First Affiliated Hospital of University of South China
-
Ta kontakt med:
- Xinhua Xiao
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210008
- Rekruttering
- Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
-
Ta kontakt med:
- Yan Bi, MD, PhD
- Telefonnummer: 86-25-83-105302
- E-post: biyan@nju.edu.cn
-
Hovedetterforsker:
- Yan Bi, MD, PhD
-
Ta kontakt med:
- Jin Li, MD, PhD
- Telefonnummer: 86-25-83-105302
- E-post: jinli807@126.com
-
Underetterforsker:
- Jin Li, MD, PhD
-
Suzhou, Jiangsu, Kina, 215006
- Rekruttering
- Department of Endocrinology, the First Affiliated Hospital of Soochow University
-
Ta kontakt med:
- Bimin Shi, MD, PhD
- Telefonnummer: 86-0512-65223637
- E-post: shibimin@163.com
-
Xuzhou, Jiangsu, Kina, 221009
- Rekruttering
- Department of Endocrinology, Xuzhou Central Hospital
-
Ta kontakt med:
- Houfa Geng
-
-
Shandong
-
Qingdao, Shandong, Kina, 266000
- Rekruttering
- Department of Endocrinology, the Affiliated Hospital of Qingdao University
-
Ta kontakt med:
- Yangang Wang
-
Weifang, Shandong, Kina, 261000
- Rekruttering
- Department of Metabolic Diseases and Weight Management, Weifang People's Hospital
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Ta kontakt med:
- Haixia Liu
-
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Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200000
- Rekruttering
- Department of Endocrinology, ZhongShan Hospital, Fudan University
-
Ta kontakt med:
- Xiaoying Li, MD, PhD
- Telefonnummer: 86-21-64041990
- E-post: li.xiaoying@zs-hospital.sh.cn
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-
Shanxi
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Xi’an, Shanxi, Kina, 710032
- Rekruttering
- Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University
-
Ta kontakt med:
- Xiangyang Liu
-
-
Yunnan
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Kunming, Yunnan, Kina, 650011
- Rekruttering
- Department of Endocrinology, the Third People's Hospital of Yunnan Province
-
Ta kontakt med:
- Li Gui
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310020
- Rekruttering
- Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Ta kontakt med:
- Jiaqiang Zhou
-
Wenzhou, Zhejiang, Kina, 325000
- Rekruttering
- Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University
-
Ta kontakt med:
- Hong Zhu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.
Tidsramme: Baseline
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Participants with MASH Stratified by Comorbidities
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Association Between Smoking and Alcohol Consumption Status and MASH Prevalence
Tidsramme: 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)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Yan Bi, MD,PhD, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. mai 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2027
Datoer for studieregistrering
Først innsendt
23. mai 2026
Først innsendt som oppfylte QC-kriteriene
2. juni 2026
Først lagt ut (Faktiske)
8. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-0142-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified participant data may be timely shared with qualified researchers upon request, subject to review and approval.
IPD-delingstidsramme
Data will become available after study completion and primary publication for 3 years.
Tilgangskriterier for IPD-deling
Data requests require a valid research proposal and signed data use agreement.
Approval is contingent on compliance with applicable laws and ethical guidelines.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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