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Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD

2. Juni 2026 aktualisiert von: 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).

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

10000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Yan Bi, MD,PhD
  • Telefonnummer: 86-25-83-105302
  • E-Mail: biyan@nju.edu

Studieren Sie die Kontaktsicherung

Studienorte

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Rekrutierung
        • Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
        • Kontakt:
          • Xiaolei Hu
      • Hefei, Anhui, China, 230601
        • Rekrutierung
        • Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
        • Kontakt:
          • Tianrong Pan
      • Wuhu, Anhui, China, 241000
        • Rekrutierung
        • Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
        • Kontakt:
          • Junfei Gu
    • Guangdong
      • Guangzhou, Guangdong, China, 510280
        • Rekrutierung
        • Department of Endocrinology, Zhujiang Hospital, Southern Medical University
        • Kontakt:
          • Jia Sun
      • Guangzhou, Guangdong, China, 511495
        • Rekrutierung
        • Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
        • Kontakt:
          • Hui Li
      • Shenzhen, Guangdong, China, 518033
        • Rekrutierung
        • Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
        • Kontakt:
          • Yunfeng Shen
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Rekrutierung
        • Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
        • Kontakt:
          • Yingfen Qin
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Rekrutierung
        • Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
        • Kontakt:
          • Xin Liao
    • Hainan
      • Haikou, Hainan, China, 570311
        • Rekrutierung
        • Department of Endocrinology, Hainan General Hospital
        • Kontakt:
          • Kaining Chen
    • Hennan
      • Zhengzhou, Hennan, China, 450099
        • Rekrutierung
        • Department of Endocrinology, the First Affiliated Hospital of Henan University of CM
        • Kontakt:
          • Suqin Shi
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Rekrutierung
        • Department of Endocrinology, Renmin Hospital of Wuhan University
        • Kontakt:
          • Ling Gao
    • Hunan
      • Hengyang, Hunan, China, 421001
        • Rekrutierung
        • Department of Endocrinology, the First Affiliated Hospital of University of South China
        • Kontakt:
          • Xinhua Xiao
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Rekrutierung
        • Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
        • Kontakt:
        • Hauptermittler:
          • Yan Bi, MD, PhD
        • Kontakt:
        • Unterermittler:
          • Jin Li, MD, PhD
      • Suzhou, Jiangsu, China, 215006
        • Rekrutierung
        • Department of Endocrinology, the First Affiliated Hospital of Soochow University
        • Kontakt:
      • Xuzhou, Jiangsu, China, 221009
        • Rekrutierung
        • Department of Endocrinology, Xuzhou Central Hospital
        • Kontakt:
          • Houfa Geng
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Rekrutierung
        • Department of Endocrinology, the Affiliated Hospital of Qingdao University
        • Kontakt:
          • Yangang Wang
      • Weifang, Shandong, China, 261000
        • Rekrutierung
        • Department of Metabolic Diseases and Weight Management, Weifang People's Hospital
        • Kontakt:
          • Haixia Liu
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Rekrutierung
        • Department of Endocrinology, ZhongShan Hospital, Fudan University
        • Kontakt:
    • Shanxi
      • Xi’an, Shanxi, China, 710032
        • Rekrutierung
        • Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University
        • Kontakt:
          • Xiangyang Liu
    • Yunnan
      • Kunming, Yunnan, China, 650011
        • Rekrutierung
        • Department of Endocrinology, the Third People's Hospital of Yunnan Province
        • Kontakt:
          • Li Gui
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310020
        • Rekrutierung
        • Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • Kontakt:
          • Jiaqiang Zhou
      • Wenzhou, Zhejiang, China, 325000
        • Rekrutierung
        • Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University
        • Kontakt:
          • Hong Zhu

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

Inclusion Criteria:

  1. Adults aged ≥18 years, with no restrictions on sex;
  2. 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:

  1. Presence of unhealed wounds, scars, or other conditions in the right upper abdominal region that are unsuitable for ultrasonographic examination;
  2. 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;
  3. History of hepatic decompensation;
  4. History of hepatectomy or liver transplantation;
  5. History of other malignancies;
  6. 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;
  7. History of transjugular intrahepatic portosystemic shunt (TIPS);
  8. 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);
  9. Clinical or subclinical hypothyroidism or hyperthyroidism.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
T2DM with MAFLD
Diagnosetest: iLivTouch (Vibration-controlled transient elastography)
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.
Zeitfenster: Baseline
Baseline

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of Participants with MASH Stratified by Comorbidities
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Association Between Smoking and Alcohol Consumption Status and MASH Prevalence
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Mitarbeiter

Fudan University
The Affiliated Hospital of Qingdao University
The First Affiliated Hospital of Soochow University
Xuzhou Central Hospital
Renmin Hospital of Wuhan University
The First Affiliated Hospital of University of South China
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Sir Run Run Shaw Hospital
Hainan General Hospital
First Affiliated Hospital of Wenzhou Medical University
Southern Medical University, China
The Second Hospital of Anhui Medical University
Zunyi Medical College
First Affiliated Hospital of Guangxi Medical University
Weifang People's Hospital
Eighth Affiliated Hospital, Sun Yat-sen University
Panyu Hospital of Traditional Chinese Medicine
The First Affiliated Hospital of Air Force Medicial University
The Third People's Hospital of Yunnan Province
The First Affiliated Hospital of Bengbu Medical University
Second Affiliated Hospital of Wannan Medical College

Ermittler

  • Hauptermittler: Yan Bi, MD,PhD, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Mai 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

31. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

23. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juni 2026

Zuerst gepostet (Tatsächlich)

8. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-0142-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified participant data may be timely shared with qualified researchers upon request, subject to review and approval.

IPD-Sharing-Zeitrahmen

Data will become available after study completion and primary publication for 3 years.

IPD-Sharing-Zugriffskriterien

Data requests require a valid research proposal and signed data use agreement. Approval is contingent on compliance with applicable laws and ethical guidelines.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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