Actively Recruiting
A Multicenter Cross-Sectional Study Evaluating the Diagnostic Accuracy of the Liver Inflammation Index for Metabolic Dysfunction-Associated Steatohepatitis in Patients With Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Fatty Liver Disease
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2026-06-08
10000
Participants Needed
22
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor
F
Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Liver Inflammation Index as a new diagnostic tool to detect Metabolic Dysfunction-Associated Steatohepatitis (MASH) in adults who have both Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD). This observational, multicenter, real-world study will collect data from 10,000 participants across 22 research centers in China, aiming to assess the clinical usefulness and accuracy of this index in identifying MASH. Participants will undergo non-invasive diagnostic testing with the iLivTouch device, which measures the Liver Inflammation Index, Ultrasound Attenuation Parameter (UAP) for liver fat grading, and Liver Stiffness Measurement (LSM) for fibrosis staging. Data collection includes comprehensive clinical information, medical history, physical exams, lifestyle questionnaires, and standard lab tests. The study includes both a large prospective cohort and a smaller retrospective cohort. During the study, researchers will gather detailed participant information including demographics, comorbid conditions, lifestyle factors, and clinical test results. They will analyze the detection rates of MASH and explore how these rates vary by liver condition severity, comorbidities, and demographics. The study also looks at the impact of lifestyle factors on MASH and will review liver-related events over a five-year period where data is available. The main outcome is the detection rate of MASH at baseline among this patient group.
CONDITIONS
Brief Title
Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older, any sex
- Clinically diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) according to Chinese Society of Hepatology guidelines
- Diagnosed with type 2 diabetes mellitus (T2DM) as per Chinese Guidelines for T2DM prevention and treatment
You will not qualify if you...
- Unhealed wounds, scars, or issues in the right upper abdominal area unsuitable for ultrasound
- Development of other liver diseases such as viral hepatitis, drug-induced liver injury, autoimmune or alcoholic liver disease
- History of hepatic decompensation
- History of liver surgery or liver transplantation
- History of other cancers
- Liver conditions including 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 with hepatic venous congestion
- History of transjugular intrahepatic portosystemic shunt (TIPS)
- Acute hepatitis or acute-on-chronic liver failure during follow-up
- Clinical or subclinical hypothyroidism or hyperthyroidism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single timepoint
Participants undergo diagnostic assessments including clinical data collection, lifestyle questionnaires, laboratory tests, and vibration-controlled transient elastography using the iLivTouch device to measure the Liver Inflammation Index, Ultrasound Attenuation Parameter, and Liver Stiffness Measurement.
1 visit (in-person)
Trial Site Locations
Total: 22 locations
1
Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233004
Actively Recruiting
2
Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
3
Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
Wuhu, Anhui, China, 241000
Actively Recruiting
4
Department of Endocrinology, Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510280
Actively Recruiting
5
Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 511495
Actively Recruiting
6
Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, China, 518033
Actively Recruiting
7
Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
8
Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563000
Actively Recruiting
9
Department of Endocrinology, Hainan General Hospital
Haikou, Hainan, China, 570311
Actively Recruiting
10
Department of Endocrinology, the First Affiliated Hospital of Henan University of CM
Zhengzhou, Hennan, China, 450099
Actively Recruiting
11
Department of Endocrinology, Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
Actively Recruiting
12
Department of Endocrinology, the First Affiliated Hospital of University of South China
Hengyang, Hunan, China, 421001
Actively Recruiting
13
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China, 210008
Actively Recruiting
14
Department of Endocrinology, the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
15
Department of Endocrinology, Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221009
Actively Recruiting
16
Department of Endocrinology, the Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
17
Department of Metabolic Diseases and Weight Management, Weifang People's Hospital
Weifang, Shandong, China, 261000
Actively Recruiting
18
Department of Endocrinology, ZhongShan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
19
Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University
Xi’an, Shanxi, China, 710032
Actively Recruiting
20
Department of Endocrinology, the Third People's Hospital of Yunnan Province
Kunming, Yunnan, China, 650011
Actively Recruiting
21
Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310020
Actively Recruiting
22
Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
Y
Yan Bi, MD,PhD
J
Jin Li, MD,PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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