Biomarkers of Steatohepatitis in Type 2 Diabetes Patients

NCT ID: NCT07098520

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-06-30

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Diabetes type 2

Patients diagnosed with type 2 diabetes

No intervention, just observation

Intervention Type: OTHER

no intervention, study investigates biomarkers associated with a disease

Interventions

No intervention, just observation

no intervention, study investigates biomarkers associated with a disease

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Type 2 diabetes diagnosis

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faculty Hospital Kralovske Vinohrady

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jan Polak

physician, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Kralovske Vinohrady

Prague, , Czechia

Countries

Czechia

Central Contacts

Jan Polak, MD, PhD

Role: CONTACT

jan.polak@lf3.cuni.cz

+420731181599

Other Identifiers

STEDIB

Identifier Type: -

Identifier Source: org_study_id