NCT07098520

Biomarkers of Steatohepatitis in Type 2 Diabetes Patients

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Faculty Hospital Kralovske Vinohrady · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diabetes
• Steatosis of Liver

Interventions

Type	Name	Description
OTHER	No intervention, just observation	no intervention, study investigates biomarkers associated with a disease

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-03-30
• Completion: 2026-06-30
• First posted: 2025-08-01
• Last updated: 2025-08-01

Locations

1 site across 1 country: Czechia