Metabolic Features Effects on FAST Score in MASLD Patients

NCT ID: NCT06867419

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

385 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Dysfunction-Associated Steatotic Liver Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MASLD patients

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

Transient Elastography

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rania Mamdouh Elkafoury

Lecturer of Tropical medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rania M Elkafoury, MD

Role: STUDY_DIRECTOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tanta University Hospitals

Tanta, Gharbyea, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rania M Elkafoury, MD

Role: CONTACT

+201004672358

Amal M Dwidar

Role: CONTACT

00201020815962

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dina H Ziada, MD

Role: primary

00201117109990

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

36264PR889/10/24

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.