Metabolic Features Effects on FAST Score in MASLD Patients

March 4, 2025 updated by: Rania Mamdouh Elkafoury, Tanta University

Metabolic Features Effect on FibroScan-AST (FAST) Score in Egyptian Patients with Metabolic-Associated Steatotic Liver Disease (MASLD)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Gharbyea
      • Tanta, Gharbyea, Egypt, 31516
        • Recruiting
        • Tanta University Hospitals
        • Contact:
        • Contact:
          • Amal M Dwidar, MD
        • Contact:
          • Ayat I Ferra, MD
        • Contact:
          • Eslam S Esmail, MD
        • Contact:
          • Amany M Dwidar, MD
        • Contact:
          • Rania M Elkafoury, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MASLD patients
385 MASLD patients who had steatosis detected by (VCTE-CAP) elastography
Radiation: Transient Elastography
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact of metabolic features on FAST score
Time Frame: 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.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Study Director: Rania M Elkafoury, MD, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR889/10/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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