Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
Recruiting · NCT07632677 · Observational (researchers observe without assigning treatment) · Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
View the official record on ClinicalTrials.gov →Interventions studied
iLivTouch (Vibration-controlled transient elastography)
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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 it is running
22 locations listed.
- Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University - Bengbu, Anhui, China
- Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University - Hefei, Anhui, China
- Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University - Wuhu, 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, the Eighth Affiliated Hospital, Sun Yat-sen University - Shenzhen, Guangdong, China
- Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University - Nanning, Guangxi, China
- Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University - Zunyi, Guizhou, China
- Department of Endocrinology, Hainan General Hospital - Haikou, Hainan, China
- Department of Endocrinology, the First Affiliated Hospital of Henan University of CM - Zhengzhou, Hennan, China
- Department of Endocrinology, Renmin Hospital of Wuhan University - Wuhan, Hubei, China
- Department of Endocrinology, the First Affiliated Hospital of University of South China - Hengyang, Hunan, China
- Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University - Nanjing, Jiangsu, China
- Department of Endocrinology, the First Affiliated Hospital of Soochow University - Suzhou, Jiangsu, China
- Department of Endocrinology, Xuzhou Central Hospital - Xuzhou, Jiangsu, China
- Department of Endocrinology, the Affiliated Hospital of Qingdao University - Qingdao, Shandong, China
- Department of Metabolic Diseases and Weight Management, Weifang People's Hospital - Weifang, Shandong, China
- Department of Endocrinology, ZhongShan Hospital, Fudan University - Shanghai, Shanghai Municipality, China
- Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University - Xi’an, Shanxi, China
- Department of Endocrinology, the Third People's Hospital of Yunnan Province - Kunming, Yunnan, China
- Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Hangzhou, Zhejiang, China
- Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University - Wenzhou, Zhejiang, China