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

2. června 2026 aktualizováno: 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).

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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).

Typ studie

Pozorovací

Zápis (Odhadovaný)

10000

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Yan Bi, MD,PhD
  • Telefonní číslo: 86-25-83-105302
  • E-mail: biyan@nju.edu

Studijní záloha kontaktů

  • Jméno: Jin Li, MD,PhD
  • Telefonní číslo: 86-25-83-105302
  • E-mail: jinli807@126.com

Studijní místa

  • Čína
    • Anhui
      • Bengbu, Anhui, Čína, 233004
        • Nábor
        • Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
        • Kontakt:
          • Xiaolei Hu
      • Hefei, Anhui, Čína, 230601
        • Nábor
        • Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
        • Kontakt:
          • Tianrong Pan
      • Wuhu, Anhui, Čína, 241000
        • Nábor
        • Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
        • Kontakt:
          • Junfei Gu
    • Guangdong
      • Guangzhou, Guangdong, Čína, 510280
        • Nábor
        • Department of Endocrinology, Zhujiang Hospital, Southern Medical University
        • Kontakt:
          • Jia Sun
      • Guangzhou, Guangdong, Čína, 511495
        • Nábor
        • Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
        • Kontakt:
          • Hui Li
      • Shenzhen, Guangdong, Čína, 518033
        • Nábor
        • Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
        • Kontakt:
          • Yunfeng Shen
    • Guangxi
      • Nanning, Guangxi, Čína, 530021
        • Nábor
        • Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
        • Kontakt:
          • Yingfen Qin
    • Guizhou
      • Zunyi, Guizhou, Čína, 563000
        • Nábor
        • Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
        • Kontakt:
          • Xin Liao
    • Hainan
      • Haikou, Hainan, Čína, 570311
        • Nábor
        • Department of Endocrinology, Hainan General Hospital
        • Kontakt:
          • Kaining Chen
    • Hennan
      • Zhengzhou, Hennan, Čína, 450099
        • Nábor
        • Department of Endocrinology, the First Affiliated Hospital of Henan University of CM
        • Kontakt:
          • Suqin Shi
    • Hubei
      • Wuhan, Hubei, Čína, 430060
        • Nábor
        • Department of Endocrinology, Renmin Hospital of Wuhan University
        • Kontakt:
          • Ling Gao
    • Hunan
      • Hengyang, Hunan, Čína, 421001
        • Nábor
        • Department of Endocrinology, the First Affiliated Hospital of University of South China
        • Kontakt:
          • Xinhua Xiao
    • Jiangsu
      • Nanjing, Jiangsu, Čína, 210008
        • Nábor
        • Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Yan Bi, MD, PhD
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Jin Li, MD, PhD
      • Suzhou, Jiangsu, Čína, 215006
        • Nábor
        • Department of Endocrinology, the First Affiliated Hospital of Soochow University
        • Kontakt:
          • Bimin Shi, MD, PhD
          • Telefonní číslo: 86-0512-65223637
          • E-mail: shibimin@163.com
      • Xuzhou, Jiangsu, Čína, 221009
        • Nábor
        • Department of Endocrinology, Xuzhou Central Hospital
        • Kontakt:
          • Houfa Geng
    • Shandong
      • Qingdao, Shandong, Čína, 266000
        • Nábor
        • Department of Endocrinology, the Affiliated Hospital of Qingdao University
        • Kontakt:
          • Yangang Wang
      • Weifang, Shandong, Čína, 261000
        • Nábor
        • Department of Metabolic Diseases and Weight Management, Weifang People's Hospital
        • Kontakt:
          • Haixia Liu
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Čína, 200000
        • Nábor
        • Department of Endocrinology, ZhongShan Hospital, Fudan University
        • Kontakt:
    • Shanxi
      • Xi’an, Shanxi, Čína, 710032
        • Nábor
        • Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University
        • Kontakt:
          • Xiangyang Liu
    • Yunnan
      • Kunming, Yunnan, Čína, 650011
        • Nábor
        • Department of Endocrinology, the Third People's Hospital of Yunnan Province
        • Kontakt:
          • Li Gui
    • Zhejiang
      • Hangzhou, Zhejiang, Čína, 310020
        • Nábor
        • Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • Kontakt:
          • Jiaqiang Zhou
      • Wenzhou, Zhejiang, Čína, 325000
        • Nábor
        • Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University
        • Kontakt:
          • Hong Zhu

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
T2DM with MAFLD
Diagnostický test: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.
Časové okno: Baseline
Baseline

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of Participants with MASH Stratified by Comorbidities
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Association Between Smoking and Alcohol Consumption Status and MASH Prevalence
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Spolupracovníci

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

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. května 2026

Primární dokončení (Odhadovaný)

31. prosince 2027

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

23. května 2026

První předloženo, které splnilo kritéria kontroly kvality

2. června 2026

První zveřejněno (Aktuální)

8. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2026-0142-01

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Časový rámec sdílení IPD

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

Kritéria přístupu pro sdílení IPD

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

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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