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. 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.
Study Type
OBSERVATIONAL
Enrollment
100
no intervention, study investigates biomarkers associated with a disease
University Hospital Kralovske Vinohrady
Prague, Czechia
Diabetologie Praha s.r.o.
Prague, Czechia
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.
Time frame: Cross sectional study - one day of clinical investigation
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.
Time frame: Cross sectional study - one day of clinical investigation
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