Testing a New Liver Inflammation Test in People With Diabetes and Fatty Liver
Checks whether a new test detects inflamed fatty liver in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
Key facts
- Where
- Bengbu, Guangzhou, Haikou, Hangzhou, Hefei, Hengyang, Kunming, Nanjing, Nanning, Qingdao, Shanghai, Shenzhen, Suzhou, Weifang, Wenzhou, Wuhan, Wuhu, Xi’an, Xuzhou, Zhengzhou, and Zunyi, ChinaSee the 22 sites
Where in China
- Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical UniversityBengbu, ChinaTaking people
- Department of Endocrinology, Zhujiang Hospital, Southern Medical UniversityGuangzhou, ChinaTaking people
- Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese MedicineGuangzhou, ChinaTaking people
- Department of Endocrinology, Hainan General HospitalHaikou, ChinaTaking people
- Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of MedicineHangzhou, ChinaTaking people
- Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical UniversityHefei, ChinaTaking people
- Department of Endocrinology, the First Affiliated Hospital of University of South ChinaHengyang, ChinaTaking people
- Department of Endocrinology, the Third People's Hospital of Yunnan ProvinceKunming, ChinaTaking people
- Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing UniversityNanjing, ChinaTaking people
- Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaTaking people
- Department of Endocrinology, the Affiliated Hospital of Qingdao UniversityQingdao, ChinaTaking people
- Department of Endocrinology, ZhongShan Hospital, Fudan UniversityShanghai, ChinaTaking people
- Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen UniversityShenzhen, ChinaTaking people
- Department of Endocrinology, the First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- Department of Metabolic Diseases and Weight Management, Weifang People's HospitalWeifang, ChinaTaking people
- Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
- Department of Endocrinology, Renmin Hospital of Wuhan UniversityWuhan, ChinaTaking people
- Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical UniversityWuhu, ChinaTaking people
- Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical UniversityXi’an, ChinaTaking people
- Department of Endocrinology, Xuzhou Central HospitalXuzhou, ChinaTaking people
- Department of Endocrinology, the First Affiliated Hospital of Henan University of CMZhengzhou, ChinaTaking people
- Department of Endocrinology, the Affiliated Hospital of Zunyi Medical UniversityZunyi, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Trial code
- NCT07632677
- Record updated
- 8 June 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: Adults aged ≥18 years, with no restrictions on sex; 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: Presence of unhealed wounds, scars, or other conditions in the right upper abdominal region that are unsuitable for ultrasonographic examination; 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; History of hepatic decompensation; History of hepatectomy or liver transplantation; History of other malignancies; 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; History of transjugular intrahepatic portosystemic shunt (TIPS); 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); Clinical or subclinical hypothyroidism or hyperthyroidism.