Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
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).
- Condition
- Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis, Metabolic Dysfunction-associated Fatty Liver Disease
- Tested
- iLivTouch (Vibration-controlled transient elastography)
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 4
- Minimum age: 18 years
- Study condition: Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis, Metabolic Dysfunction-associated Fatty Liver Disease
- 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 9
- 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.
Where
22 sites, 22 recruiting
Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
Bengbu, 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, Hainan General Hospital
Haikou, Hainan, China
Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
and 16 more sites on ClinicalTrials.gov
Contact
-
Yan Bi, MD,PhD
86-25-83-105302 biyan@nju.edu
-
Jin Li, MD,PhD
86-25-83-105302 jinli807@126.com
Potential match only. Final eligibility is determined by the study team.