Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT06867419
Metabolic Features Effects on FAST Score in MASLD Patients
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Transient Elastography
- Type of treatment
- Surgery or procedure
- How many people
- 385 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects from the outpatient clinic of the Tropical Medicine and Infectious Diseases Department at Tanta University Hospitals
Who may be able to join
- All patients with MASLD who had steatosis detected by (VCTE-CAP) elastography
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Gharbyea, 31516
Dina H Ziada, MD, 00201117109990, dina.ziada@med.tanta.edu.eg
Amal M Dwidar, MD
About this study
Official title: 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.
- Being tested
- Transient Elastography
- Keywords
- Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD), FAST Score, Metabolic Features
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient ElastographyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| MASLD patients | 385 MASLD patients who had steatosis detected by (VCTE-CAP) elastography Receives: Radiation: Transient Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Sep 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mamdouh Elkafoury, Tanta University
- Investigators
- Rania M Elkafoury, MD, Study director, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867419
- Sponsor's protocol ID
- 36264PR889/10/24
- Status last verified
- Mar 2025
- First submitted
- 13 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Features Effect on FibroScan-AST (FAST) Score in Egyptian Patients With Metabolic-Associated Steatotic Liver Disease (MASLD)
- ClinicalTrials.gov ID
- NCT06867419
- Acronym / sponsor ID
- 36264PR889/10/24
- Keywords
- Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD), FAST Score, Metabolic Features
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MASLD patients | – | Radiation: Transient Elastography385 MASLD patients who had steatosis detected by (VCTE-CAP) elastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects from the outpatient clinic of the Tropical Medicine and Infectious Diseases Department at Tanta University Hospitals
Key inclusion criteria (1 listed)
- All patients with MASLD who had steatosis detected by (VCTE-CAP) elastography
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transient Elastographyparticipants 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. | Radiation | MASLD patients |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rania M Elkafoury, MD study director
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rania M Elkafoury, MD (+201004672358, rania.elkafoury@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact of metabolic features on FAST score (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.