RecruitingNCT07632677

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

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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

10,000 participants

Start Date

May 15, 2026

Study Type

OBSERVATIONAL

Conditions

Type 2 Diabetes Mellitus (T2DM)MASH - Metabolic Dysfunction-Associated Steatohepatitis Metabolic Dysfunction-associated Fatty Liver Disease

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying iLivTouch (Vibration-controlled transient elastography) for people with mash - metabolic dysfunction-associated steatohepatitis, metabolic dysfunction-associated fatty liver disease, and other related conditions. The study is currently recruiting participants at 22 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTiLivTouch (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.

Locations(22)

Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University

Wuhu, Anhui, China

Department of Endocrinology, Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University

Shenzhen, Guangdong, China

Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Department of Endocrinology, Hainan General Hospital

Haikou, Hainan, China

Department of Endocrinology, the First Affiliated Hospital of Henan University of CM

Zhengzhou, Hennan, China

Department of Endocrinology, Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Department of Endocrinology, the First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, China

Department of Endocrinology, the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Department of Endocrinology, Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Department of Endocrinology, the Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Department of Metabolic Diseases and Weight Management, Weifang People's Hospital

Weifang, Shandong, China

Department of Endocrinology, ZhongShan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University

Xi’an, Shanxi, China

Department of Endocrinology, the Third People's Hospital of Yunnan Province

Kunming, Yunnan, China

Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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