Biomarkers of Steatohepatitis in Type 2 Diabetes Patients

NCT07098520 | Not Yet Recruiting

• 1 other identifier: STEDIB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Steatosis of Liver

Outcome Measures

Primary Outcomes (1)

• 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.

  Cross sectional study - one day of clinical investigation

Secondary Outcomes (1)

• ELF (Enhanced Liver Fibrosis) score

  Cross sectional study - one day of clinical investigation

Study Arms (1)

Diabetes type 2

Patients diagnosed with type 2 diabetes

Other: No intervention, just observation

Interventions

No intervention, just observation OTHER

no intervention, study investigates biomarkers associated with a disease

Diabetes type 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with Type 2 diabetes mellitus

You may qualify if:

• Type 2 diabetes diagnosis

You may not qualify if:

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

Sponsors & Collaborators

• Faculty Hospital Kralovske Vinohrady: lead

Study Sites (1)

University Hospital Kralovske Vinohrady

Prague, 100 00, Czechia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum aliquots

MeSH Terms

Conditions

Diabetes Mellitus; Fatty Liver

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Liver Diseases; Digestive System Diseases

Central Study Contacts

Jan Polak, MD, PhD

CONTACT

+420731181599; jan.polak@lf3.cuni.cz

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician, principal investigator

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: August 1, 2025
• Study Start: September 1, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be made available starting 6 months after the study completion date for 10 years.
• Access Criteria: Access to the data will be granted following the review and approval of a research proposal and a signed Data Sharing Agreement (DSA). Requests for access can be submitted via email to jan.polak@lf3.cuni.cz

Locations

CZ (1)