Metabolic Features Effects on FAST Score in MASLD Patients

Recruiting

• Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease

• Registration Number: NCT06867419
• Lead Sponsor: Tanta University

Brief Summary

The goal of this observational cross-sectional study is to evaluate the effect of metabolic features on Fibroscan-AST (FAST) score stratification in metabolic dysfunction-associated steatotic liver disease (MASLD) patients in Egypt.

Researchers will identify the metabolic risk factors in patients with MASLD. evaluate the effect of metabolic features on stratifying MASLD patients by predicting higher FAST score.

Participants will be subjected to history taking, clinical examination, laboratory investigations, abdominal ultrasonography, and transient elastography (Fibroscan) to measure liver stiffness (LSM) and controlled attenuation parameter (CAP). The Non-alcoholic fatty liver disease (NAFLD) fibrosis score and FAST score will be calculated.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Study First Submitted: 2025-02-13
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

• All patients with MASLD who had steatosis detected by (VCTE-CAP) elastography

Exclusion Criteria

• Patients with a history of significant alcohol consumption more than 30 g/day in men and > 20 g/day in women.
• Patients with positive hepatitis B or C virus markers.
• Patients with autoimmune hepatitis.
• Patients with any other metabolic liver disease.
• Patients with hepatic focal lesions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
impact of metabolic features on FAST score	through study completion, an average of 6 months	Calculating the FAST score by combining AST (IU/L) with LSM (kPa) and CAP (dB/m2) measured by Fibroscan for all MASLD patients. Evaluation of which metabolic features (DM, HTN, obesity, dyslipidemia) would be associated with a higher FAST score indicating having steatohepatitis with significant inflammatory activity and fibrosis.

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Gharbyea, Egypt