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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who have both type 2 diabetes and metabolic dysfunction-associated fatty liver disease (MAFLD). It tests a new tool, the Liver Inflammation Index, for finding MASH.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Diagnosed MAFLD and diagnosed type 2 diabetes, both based on the Chinese guidelines (2024 Edition)
Main reasons for not taking part
- Unhealed wounds or scars in the right upper belly that make an ultrasound unsuitable
- Other liver diseases, such as viral hepatitis, drug-induced liver injury, autoimmune or alcoholic liver disease
- History of hepatic decompensation, liver surgery (hepatectomy) or liver transplantation
- History of other cancers
- Thyroid disease (hypothyroidism or hyperthyroidism)
Read by machine on 9 November 2026.
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.