DiabetesSTEDIBNCT07098520
Biomarkers of Steatohepatitis in Type 2 Diabetes Patients
An observational study of Diabetes and Steatosis of Liver, run by Faculty Hospital Kralovske Vinohrady at 2 sites in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, Steatosis of Liver
- How many people
- 100 participants
- Where
- 2 sitesCzechia
- Study dates
- 18 Apr 2024to 30 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18-75 years with type 2 diabetes mellitus and suspected liver involvement, consecutively recruited during routine outpatient diabetes visits. Suspected liver involvement was defined by ultrasonographically detected hepatic steatosis, or hepatomegaly, or liver enzyme elevation above the applicable laboratory upper limit of normal.
Who may be able to join
- Age 18 to 75 years, inclusive.
- Diagnosis of type 2 diabetes mellitus, irrespective of glucose-lowering treatment.
- Suspected liver involvement, defined by at least one of the following:
- Ultrasonographically detected hepatic steatosis;
- Hepatomegaly; or
- Elevation of liver enzymes above the applicable laboratory upper limit of normal.
- Written informed consent.
Who cannot join
- Failure to meet the study-specific alcohol-related eligibility criteria described below.
- History of other liver disease.
- Concurrent acute inflammatory disease.
- Unstable or decompensated chronic disorders, including heart failure, respiratory failure, kidney failure, or thyroid gland disorders.
- Concurrent oncological diagnosis or treatment.
- Alcohol-related eligibility criteria:
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- Alcohol consumption was assessed at recruitment using a structured verbal interview. Questions 1-3 were based on AUDIT-C and covered the preceding 12 months. Question 4 addressed lifetime history.
- All of the following response requirements had to be met:
- Question 1: "How often did you have a drink containing alcohol in the past year?" Eligible responses were "never" (0 points), "monthly or less"
- (1 point), or "2-4 times a month" (2 points).
- Question 2: "How many drinks containing alcohol did you have on a typical day when you were drinking in the past year?" Among participants who drank alcohol, only 1-2 drinks (0 points) was accepted. Usual quantity was not applicable to abstainers.
- Question 3: "How often did you have six or more drinks on one occasion in the past year?" Only "never" (0 points) was accepted.
- Question 4: "Was there ever a period in your life when you drank more than indicated by your responses to questions 1-3?" Only "no, never" was accepted.
- The lifetime-history question was assessed separately and was not added to the AUDIT-C total. Eligibility depended on the specified item-level responses, not merely on a total AUDIT-C score of 0-2. The same criteria applied to women and men.
- One local serving was defined as 500 mL of beer, 200 mL of wine, or 50 mL of spirits. These volumes were not assumed to contain identical amounts of ethanol.
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
University Hospital Kralovske Vinohrady
Prague, 100 00
Diabetologie Praha s.r.o.
Prague, 10000
About this study
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.
Read the detailed description
Hepatic steatosis, known as non-alcoholic fatty liver disease (NAFLD), is prevalent among type 2 diabetes mellitus patients. NAFLD encompasses benign hepatic steatosis and non-alcoholic steatohepatitis (NASH), the latter being a hepatic complication linked to metabolic syndrome. Insulin resistance and dysregulation of fatty acid metabolism contribute to its pathogenesis, leading to oxidative stress, hepatocyte damage, and fibroproduction, eventually progressing to cirrhosis and hepatocellular carcinoma.
Identification of high-risk NAFLD patients, particularly those with NASH, is crucial for early intervention and monitoring. However, distinguishing between benign steatosis and NASH poses a clinical challenge. Liver biopsy remains the gold standard for NASH diagnosis but is invasive and impractical for routine screening in diabetic patients.
The study aims to identify high-risk type 2 diabetics prone to NASH progression by correlating clinical and laboratory parameters with sonographic and elastographic findings. Parameters such as diabetes duration, BMI, waist/hip ratio, glycated hemoglobin, and liver function tests will be compared with real-time shear wave elastography results. This approach seeks to pinpoint indicators of liver fibrosis (NASH), facilitating targeted screening and intensified management of type 2 diabetes mellitus, potentially averting NASH complications.
Data collection has been completed for the initial group of 40 participants. The overall STEDIB study remains ongoing, with further recruitment and data collection planned under the study protocol.
- Conditions
- Diabetes, Steatosis of Liver
- Being tested
- No intervention, just observation
- Medical subject headings
- Diabetes Mellitus, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, just observationOther
no intervention, study investigates biomarkers associated with a disease
| Study group | Role | What they receive |
|---|---|---|
| Diabetes type 2 | Patients diagnosed with type 2 diabetes Receives: Other: No intervention, just observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIB-4 (Fibrosis-4) index
FIB-4 index - marker of liver fibrosis (calculated from variables provided below) will be evaluated in all subjects.
FIB-4 index is calculated as follows: FIB-4 = (Age × AST) / (Platelets × √ALT). This requires values: the patient's age in years, AST (aspartate aminotransferase) in U/L, ALT (alanine aminotransferase) in U/L, and platelet count in 10^9/L.
A score below 1.3 suggests minimal fibrosis, while a score above 3.25 indicates advanced fibrosis.
Measured: Cross sectional study - one day of clinical investigation
Secondary outcomes (1)
ELF (Enhanced Liver Fibrosis) score
ELF (Enhanced Liver Fibrosis) score will be determined in all subjects.
The ELF score is calculated as follows: ELF score = 2.278 + 0.851 × ln(HA) + 0.751 × ln(PIIINP) + 0.394 × ln(TIMP-1), where HA represents serum concentration of hyaluronic acid in ng/mL, PIINP represents serum concentration of procollagen III N-terminal peptide in ng/mL and TIMP-1 represents serum concentration of tissue inhibitor of metalloproteinase in ng/mL.
The reference range of the ELF score (7.14-9.55), higher values suggest more advanced liver fibrosis.
Measured: Cross sectional study - one day of clinical investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start18 Apr 2024
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jan Polak, Faculty Hospital Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098520
- Sponsor's protocol ID
- STEDIB
- Acronym
- STEDIB
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data from completed STEDIB cohorts may be shared with qualified researchers upon reasonable request.