Biomarkers of Steatohepatitis in Type 2 Diabetes Patients (STEDIB)

Faculty Hospital Kralovske Vinohrady

Status: Not yet enrolling

Conditions: Steatosis of Liver; Diabetes

Treatments: Other: No intervention, just observation

Study type: Observational

Funder types: Other

Identifiers

NCT07098520

STEDIB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Type 2 diabetes diagnosis

Exclusion criteria

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

Trial design

100 participants in 1 patient group

Diabetes type 2

Description:

Patients diagnosed with type 2 diabetes

Treatment:

Other: No intervention, just observation