Metabolic Features Effects on FAST Score in MASLD Patients

NCT06867419 | Recruiting

• 1 other identifier: 36264PR889/10/24
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD); FAST Score; Metabolic Features

Outcome Measures

Primary Outcomes (1)

• impact of metabolic features on FAST score

  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.

  through study completion, an average of 6 months

Study Arms (1)

MASLD patients

385 MASLD patients who had steatosis detected by (VCTE-CAP) elastography

Radiation: Transient Elastography

Interventions

Transient Elastography RADIATION

participants will be subjected to anthropometric measurements, laboratory investigations (complete blood count, liver and kidney functions, lipid profile, virology tests, fasting insulin, fasting sugar, 2 hour postprandial sugar, HbA1c, and HOMA-IR), radiological examination (abdominal ultrasound, Fibroscan). the NAFLD fibrosis score, APRI, FIB-4 score, and FAST score will be calculated.

MASLD patients

Eligibility Criteria

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

Study Population

subjects from the outpatient clinic of the Tropical Medicine and Infectious Diseases Department at Tanta University Hospitals

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

RECRUITING

Study Officials

• Rania M Elkafoury, MD

  Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

  STUDY DIRECTOR

Central Study Contacts

Rania M Elkafoury, MD

CONTACT

+201004672358; rania.elkafoury@med.tanta.edu.eg

Amal M Dwidar

CONTACT

00201020815962; amal.mohammed@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Tropical medicine

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: March 10, 2025
• Study Start: September 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

EG (1)