Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD (NCT07632677) | Clinical Trial Compass
RecruitingNot Applicable
Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
China10,000 participantsStarted 2026-05-15
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying a 'Liver Inflammation Index' to detect MASH in people who already have Type 2 diabetes and fatty liver disease — could you explain what this index actually measures, and whether it might give us useful information about the state of my liver without needing a biopsy?
2Since this appears to be a diagnostic study rather than a treatment trial, would joining it expose me to any procedures or tests beyond what I'd normally have, and are there any risks I should know about?
3The trial is focused on a Chinese population with both T2DM and MAFLD — given my own background and health profile, do you think the findings from this study would actually be relevant to my situation?
4While this study looks at how well a test detects MASH, it doesn't seem to involve any new treatment — so should I also be looking into treatment-focused trials or established therapies for MASH at the same time?
5If the Liver Inflammation Index used in this trial turns out to flag that I might have MASH, what would the next steps in my care look like, and would that change anything about how we're currently managing my diabetes or fatty liver disease?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.
Timeframe: Baseline
Trial details
NCT IDNCT07632677
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
. 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);