NCT07632677 Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
| NCT ID | NCT07632677 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Type 2 Diabetes Mellitus (T2DM) |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2026-05-15 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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.
Contact & Investigator
Yan Bi, MD,PhD
PRINCIPAL INVESTIGATOR
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Frequently Asked Questions
Who can join the NCT07632677 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes Mellitus (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07632677 currently recruiting?
Yes, NCT07632677 is actively recruiting participants. Contact the research team at biyan@nju.edu for enrollment information.
Where is the NCT07632677 trial being conducted?
This trial is being conducted at Bengbu, China, Hefei, China, Wuhu, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT07632677 clinical trial?
NCT07632677 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The principal investigator is Yan Bi, MD,PhD at Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University. The trial plans to enroll 10,000 participants.
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