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NCT07632677Recruiting

Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD

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

Source: ClinicalTrials.gov · Last updated 8 Jun 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
10000 (estimated)
First submitted
23 May 2026
Start date
15 May 2026
Primary completion date
31 Dec 2027
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
NCT number
NCT07632677

What you commit to

  • Study type: Observational
  • Planned participants: 10000
  • From 15 May 2026 to the primary completion date, 31 Dec 2027
  • 22 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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);

Other

  • Clinical or subclinical hypothyroidism or hyperthyroidism.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
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BengbuChinaRecruiting
Department of Endocrinology, Zhujiang Hospital, Southern Medical University
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GuangzhouChinaRecruiting
Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
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GuangzhouChinaRecruiting
Department of Endocrinology, Hainan General Hospital
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HaikouChinaRecruiting
Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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HangzhouChinaRecruiting
Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
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HefeiChinaRecruiting
Department of Endocrinology, the First Affiliated Hospital of University of South China
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HengyangChinaRecruiting
Department of Endocrinology, the Third People's Hospital of Yunnan Province
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KunmingChinaRecruiting
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
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NanjingChinaRecruiting
Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
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NanningChinaRecruiting
Department of Endocrinology, the Affiliated Hospital of Qingdao University
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QingdaoChinaRecruiting
Department of Endocrinology, ZhongShan Hospital, Fudan University
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ShanghaiChinaRecruiting
Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
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ShenzhenChinaRecruiting
Department of Endocrinology, the First Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
Department of Metabolic Diseases and Weight Management, Weifang People's Hospital
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WeifangChinaRecruiting
Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
Department of Endocrinology, Renmin Hospital of Wuhan University
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WuhanChinaRecruiting
Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
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WuhuChinaRecruiting
Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University
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Xi’anChinaRecruiting
Department of Endocrinology, Xuzhou Central Hospital
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XuzhouChinaRecruiting
Department of Endocrinology, the First Affiliated Hospital of Henan University of CM
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ZhengzhouChinaRecruiting
Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
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ZunyiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.