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

Recruitingn/aAges 18 Years - anyAllThe Affiliated Nanjing Drum Tower Hospital of Nan…
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adults aged ≥18 years, with no restrictions on sex; 2. 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: 1. Presence of unhealed wounds, scars, or other conditions in the right upper abdominal region that are unsuitable for ultrasonographic examination; 2. 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; 3. History of hepatic decompensation; 4. History of hepatectomy or liver transplantation; 5. History of other malignancies; 6. 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; 7. History of transjugular intrahepatic portosystemic shunt (TIPS); 8. 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); 9. Clinical or subclinical hypothyroidism or hyperthyroidism.
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What it tests

  • iLivTouch (Vibration-controlled transient elastography)
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Where

22 sites
Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
Bengbu, China
Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
Hefei, China
Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
Wuhu, China
Department of Endocrinology, Zhujiang Hospital, Southern Medical University
Guangzhou, China
Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
Guangzhou, China
Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, China
Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
Nanning, China
Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
Zunyi, China

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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