Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
Recruiting now
Conditions studied: Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis, Metabolic Dysfunction-associated Fatty Liver Disease
In brief
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).
Key facts
- Study ID
- NCT07632677
- Run by
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- People needed
- 10000
- Starts
- 2026-05-15
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-06-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
- Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China (enrolling)
- Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
- Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University — Wuhu, Anhui, China (enrolling)
- Department of Endocrinology, Zhujiang Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)
- Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China (enrolling)
- Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University — Shenzhen, Guangdong, China (enrolling)
- Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (enrolling)
- Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (enrolling)
- Department of Endocrinology, Hainan General Hospital — Haikou, Hainan, China (enrolling)
- Department of Endocrinology, the First Affiliated Hospital of Henan University of CM — Zhengzhou, Hennan, China (enrolling)
- Department of Endocrinology, Renmin Hospital of Wuhan University — Wuhan, Hubei, China (enrolling)
- Department of Endocrinology, the First Affiliated Hospital of University of South China — Hengyang, Hunan, China (enrolling)
- Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University — Nanjing, Jiangsu, China (enrolling)
- Department of Endocrinology, the First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
- Department of Endocrinology, Xuzhou Central Hospital — Xuzhou, Jiangsu, China (enrolling)
- Department of Endocrinology, the Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (enrolling)
- Department of Metabolic Diseases and Weight Management, Weifang People's Hospital — Weifang, Shandong, China (enrolling)
- Department of Endocrinology, ZhongShan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
- Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University — Xi’an, Shanxi, China (enrolling)
- Department of Endocrinology, the Third People's Hospital of Yunnan Province — Kunming, Yunnan, China (enrolling)
- Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
- Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (enrolling)
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