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Recruiting Observational

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

NCT07632677 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-05-15
Last updated
2026-06-08

Condition(s) studied

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

Investigational drug(s) / intervention(s)

iLivTouch (Vibration-controlled transient elastography)

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population. — Baseline

Trial sites (22)

FacilityCityRegionStatus
Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University Bengbu Anhui Recruiting
Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University Hefei Anhui Recruiting
Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University Wuhu Anhui Recruiting
Department of Endocrinology, Zhujiang Hospital, Southern Medical University Guangzhou Guangdong Recruiting
Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine Guangzhou Guangdong Recruiting
Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University Shenzhen Guangdong Recruiting
Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University Nanning Guangxi Recruiting
Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University Zunyi Guizhou Recruiting
Department of Endocrinology, Hainan General Hospital Haikou Hainan Recruiting
Department of Endocrinology, the First Affiliated Hospital of Henan University of CM Zhengzhou Hennan Recruiting
Department of Endocrinology, Renmin Hospital of Wuhan University Wuhan Hubei Recruiting
Department of Endocrinology, the First Affiliated Hospital of University of South China Hengyang Hunan Recruiting
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University Nanjing Jiangsu Recruiting
Department of Endocrinology, the First Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting
Department of Endocrinology, Xuzhou Central Hospital Xuzhou Jiangsu Recruiting
Department of Endocrinology, the Affiliated Hospital of Qingdao University Qingdao Shandong Recruiting
Department of Metabolic Diseases and Weight Management, Weifang People's Hospital Weifang Shandong Recruiting
Department of Endocrinology, ZhongShan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting
Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University Xi’an Shanxi Recruiting
Department of Endocrinology, the Third People's Hospital of Yunnan Province Kunming Yunnan Recruiting
Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07632677 on ClinicalTrials.gov ↗ ← All trials in China