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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.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
University Hospital Kralovske Vinohrady
Prague, Czechia
Start Date
September 1, 2025
Primary Completion Date
March 30, 2026
Completion Date
June 30, 2026
Last Updated
August 1, 2025
100
ESTIMATED participants
No intervention, just observation
OTHER
Lead Sponsor
Faculty Hospital Kralovske Vinohrady
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07296484