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Completed

NCT Number: NCT07098520

Biomarkers of Steatohepatitis in Type 2 Diabetes Patients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Kralovske Vinohrady

Prague, 100 00, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Type 2 diabetes diagnosis

Exclusion criteria

Alcohol abuse (anamnestic) Hepatitis Other known liver disease (other than steatosis/steatohepatitis)

Treatment and study plan

No intervention, just observation

Other

no intervention, study investigates biomarkers associated with a disease

Primary outcomes

  1. FIB-4 (Fibrosis-4) index

    Time frame: Cross sectional study - one day of clinical investigation

    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.

Secondary outcomes

  1. ELF (Enhanced Liver Fibrosis) score

    Time frame: Cross sectional study - one day of clinical investigation

    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.

Sponsors and collaborators

Lead sponsor

Faculty Hospital Kralovske Vinohrady

Other Gov

Registry information

Acronym: STEDIB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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