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Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
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).
ClinicalTrials.gov IDNCT07632677
PhaseNot Applicable
Enrollment10000
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Age18 Years and older
SexALL
Conditions studied
Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis, Metabolic Dysfunction-associated Fatty Liver Disease
About this study
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).
Interventions
- Diagnostic 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.
Primary outcomes
- To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population. (Baseline)
Eligibility information
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.
Study locations
- Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui 233004 China
- Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230601 China
- Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University, Wuhu, Anhui 241000 China
- Department of Endocrinology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong 510280 China
- Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong 511495 China
- Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University, Shenzhen, Guangdong 518033 China
- Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021 China
- Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou 563000 China
- Department of Endocrinology, Hainan General Hospital, Haikou, Hainan 570311 China
- Department of Endocrinology, the First Affiliated Hospital of Henan University of CM, Zhengzhou, Hennan 450099 China
Showing 10 of 22 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-21.