Biomarkers of Steatohepatitis in Type 2 Diabetes Patients (NCT07098520) | Clinical Trial Compass
CompletedNot Applicable
Biomarkers of Steatohepatitis in Type 2 Diabetes Patients
Czechia40 participantsStarted 2025-09-01
Plain-language summary
The aims of the study are to identify a subgroup of type 2 diabetics at risk of developing and progressing to non-alcoholic steatohepatitis (NASH), to correlate clinical and laboratory parameters with sonographic and elastographic findings in order to pinpoint indicators of liver fibrosis (NASH), and to facilitate targeted screening and intensified management of type 2 diabetes mellitus to prevent NASH complications.
Who can participate
Age range
18 Years – 75 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:
Type 2 diabetes diagnosis
Exclusion Criteria:
Alcohol abuse (anamnestic) Hepatitis Other known liver disease (other than steatosis/steatohepatitis)
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 has already been completed — can you tell me if any results have been published yet, and whether the FIB-4 findings might change how you would monitor my liver health given that I have type 2 diabetes?
2Since this study focused on identifying biomarkers like the FIB-4 index in people with type 2 diabetes and liver steatosis, do you think I should have my FIB-4 score calculated as part of my current care?
3The trial looked at steatohepatitis — which is liver inflammation on top of fatty liver — how likely is it that my condition has progressed to that stage, and would the biomarkers studied here help us figure that out?
4Given that this was an observational biomarker study rather than a treatment trial, are there any actual treatment trials you would recommend I look into based on my liver and diabetes status?
5Is the FIB-4 index something you already use in your practice to assess liver fibrosis risk in patients like me, or is it still considered experimental in this context?
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
FIB-4 (Fibrosis-4) index
Timeframe: Cross sectional study - one day of clinical investigation