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NCT Number: NCT06867419

Metabolic Features Effects on FAST Score in MASLD Patients

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.

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Key information

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

Location status: Recruiting

Location contact

Amal M Dwidar, MD

PRINCIPAL_INVESTIGATOR

Amany M Dwidar, MD

SUB_INVESTIGATOR

Ayat I Ferra, MD

SUB_INVESTIGATOR

Dina H Ziada, MD

CONTACT

[email protected]

00201117109990

Eslam S Esmail, MD

SUB_INVESTIGATOR

Rania M Elkafoury, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amal M Dwidar

CONTACT

[email protected]

00201020815962

Rania M Elkafoury, MD

CONTACT

[email protected]

+201004672358

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Mar 10, 2025
Registry last updated: Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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