Metabolic- Associated Fatty Liver Disease (MAFLD)NCT06492369
MAFLD Fibrosis Score for Detecting Fibrotic NASH in MAFLD Egyptian Patients
An observational study of Metabolic- Associated Fatty Liver Disease (MAFLD), run by Tanta University at 1 site in Egypt.
Trial summary
Metabolic-associated fatty liver disease (MAFLD), is a metabolic stress-induced liver injury characterized by diffuse hepatocyte macrovesicular fatty infiltration. The incidence of MAFLD is increasing yearly, and its incidence rate is as high as 20% to 30% on a global scale, which seriously affects people's health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic- Associated Fatty Liver Disease (MAFLD)
- How many people
- 382 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: NAFLD patients attending Tanta Tropical Medicine outpatient clinic, faculty of medicine.
Who may be able to join
- Male or female patients older than 18 years.
- NAFLD Patients assessed by ultrasound, fibroscan.
Who cannot join
- Patients aged < 18 years
- pregnant women.
- Excess alcohol intake (more than 30 g in men and 20 g in women).
- Viral hepatitis.
- Autoimmune hepatitis
- secondary fatty liver (e.g., the use of systemic steroids or methotrexate).
- history of malignancy in the past 2 years.
- Unwilling to participate in our study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tropical medicine department, Tanta University Hospitals
Tanta, Gharbyea, 31527
About this study
Official title: The Accuracy of MAFLD Fibrosis Score in Detecting Fibrotic NASH in MAFLD Egyptian Patients
Metabolic-associated fatty liver disease (MAFLD), is a metabolic stress-induced liver injury characterized by diffuse hepatocyte macrovesicular fatty infiltration.
The incidence of MAFLD is increasing yearly, and its incidence rate is as high as 20% to 30% on a global scale, which seriously affects people's health. Non-alcoholic steatohepatitis (NASH), a chronic hepatitis that can progress to advanced fibrosis, decompensated cirrhosis, and hepatocellular carcinoma, affects one-fifth of NAFLD patients. Depending on the histological severity of fibrosis, patients with NASH can be further classified as early NASH (F0-F1 fibrosis), fibrotic NASH (≥F2 fibrosis), or NASH-cirrhosis (F4 fibrosis).
Read more
Identifying subjects with fibrotic NASH is essential as they are at risk of complications, and disease progression and may benefit from potential pharmacological therapy.
Assessment of fibrotic NASH ranges from noninvasive scores to percutaneous liver biopsy, but liver biopsy is invasive and limited by cost, sampling variability, and intrareader/interreader variability.
Noninvasive modalities to risk stratify fibrotic NASH include serum biomarkers, imaging, and algorithms combining both. The FibroScan-AST (FAST) composite score is based on the liver stiffness measure (LSM), controlled attenuation potential (CAP), and AST. At the cut-off of a FAST score ≥0.67, biopsy-proven fibrotic NASH (NAFLD with a histological NAFLD activity score [NAS] ≥4 and fibrosis ≥2) can be ruled in with 90% specificity.
A new predictive model was recently developed based on eight variables (age, BMI, HbA1c, history of type 2 diabetes, International normalized ratio (INR), AST, Gamma Glutamyl transferase (GGT), and platelet count). A composite score MAFLD Fibrosis Score (MFS) was calculated as: MFS = 0.078 × Age (year)-0.007363 × Platelet count (109/L) + 0.0146 × AST (U/L) + 0.007618 × GGT (U/L) + 6.673 × INR + 0.09833 × BMI (kg/m2) + 1.425 × type 2 diabetes (yes = 1, no = 0).
So, in this study, the investigators will try to evaluate the accuracy of the new emerging predictor MAFLD Fibrosis Score (MFS) vs AST- to-platelet ratio index (APRI) score, fibrosis-4 index (FIB-4) score, and NAFLD fibrosis score in the assessment of the fibrotic NASH in Egyptian NAFLD patients.
Read the detailed description
This study will be a cross-sectional study and will be carried out on 380 MAFLD patients attending to Tanta tropical medicine outpatient clinic, faculty of medicine. The start of the research will be in March 2024 to August 2024 or until collecting the cases.
Sample size The study will be carried on 382 patients according to the prevalence in Egypt 47.5% with confidence level 95% and margin of error 5 All the patients will be subjected to;
History taking:
Full history taking including:
- Personal history (name, age, sex, occupation, residence and marital state).
- Anthropometric measures: weight, length, BMI, Waist circumference.
- Complaint.
Investigations:
- Complete blood picture (CBC).
- Lipid profile (triglycerides, HDL, LDL, cholesterol level).
- Fasting Blood glucose level and or HBA1C.
- Liver functions (ALT, AST, INR, GGT, albumin, bilirubin).
- Viral markers and Anti-nuclear antibody (ANA). Data of radiological examination
- Fibroscan: Liver fibrosis and steatosis can be staged using Dimensional ultrasound transient elastography (TE).
- Ultrasound on abdomen and pelvis for evaluation of liver condition.
- Fibrotic NASH was diagnosed with FAST score with a cut-off ≥0.67, biopsy-proven fibrotic NASH (NAFLD with a histological NAFLD activity score [NAS] ≥4 and fibrosis ≥2). [8]
- MAFLD fibrosis score (MFS) is calculated using the formula:
MFS = 0.078 × Age (year)-0.007363 × Platelet count (109/L) + 0.0146 × AST (U/L) + 0.007618 × GGT (U/L) + 6.673 × INR + 0.09833 × BMI (kg/m2) + 1.425 × type 2 diabetes (yes = 1, no = 0).[9] - The FIB-4 index is calculated using the formula: FIB-4= Age (years)×AST(U/L)/ [platelet (109/L) ×ALT 1/2 (U/L)].
- NAFLD fibrosis score (NFS) is calculated using the formula: NFS = -1.675 + 0.037 × age (year) + 0.094 × BMI (kg/m2) + 1.13 × impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet count (×109/L) - 0.66 × albumin (g/dL).
Ethical considerations:
- A written informed consent form authorizing the collection of this data was signed by all patients.
- The study will be approved by the Ethical Committee of the Faculty of Medicine at Tanta University.
The risks to the participants and measures needed to minimize these risks:
- The privacy of the data of the patients will be maintained (the procedure will be discussed later in this protocol.
- Any unexpected risks appeared during the course of research will be cleared to the patients and the ethical committee on time.
Adequate provisions to maintain privacy of participants and confidentially of data are as follow:
- A code number for each patient will be used, symbols to the name and address will be kept in a special file.
- The investigators will hide the patients' names when the research is used.
- The investigators will use the results of the research only in scientific aim and not use it in other
- Keywords
- Metabolic- associated fatty liver disease (MAFLD), Fibrotic NASH, MAFLD fibrosis score (MFS)
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of MFS in detecting Fibrotic NASH
evaluation of accuracy of MAFLD Fibrosis Score (MFS) in the assessment of the fibrotic NASH in Egyptian patients.
Measured: till August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start15 Mar 2024
- Primary completion30 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic- Associated Fatty Liver Disease (MAFLD)Studies 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
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mamdouh Elkafoury, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492369
- Sponsor's protocol ID
- 36264PR614/3/24
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2024
- Last updated
- 6 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of MAFLD Fibrosis Score in Detecting Fibrotic NASH in MAFLD Egyptian Patients
- ClinicalTrials.gov ID
- NCT06492369
- Acronym / sponsor ID
- 36264PR614/3/24
- Keywords
- Metabolic- associated fatty liver disease (MAFLD), Fibrotic NASH, MAFLD fibrosis score (MFS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 9 Jul 2024 (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.
Metabolic-associated fatty liver disease (MAFLD), is a metabolic stress-induced liver injury characterized by diffuse hepatocyte macrovesicular fatty infiltration.
The incidence of MAFLD is increasing yearly, and its incidence rate is as high as 20% to 30% on a global scale, which seriously affects people's health. Non-alcoholic steatohepatitis (NASH), a chronic hepatitis that can progress to advanced fibrosis, decompensated cirrhosis, and hepatocellular carcinoma, affects one-fifth of NAFLD patients. Depending on the histological severity of fibrosis, patients with NASH can be further classified as early NASH (F0-F1 fibrosis), fibrotic NASH (≥F2 fibrosis), or NASH-cirrhosis (F4 fibrosis).
Identifying subjects with fibrotic NASH is essential as they are at risk of complications, and disease progression and may benefit from potential pharmacological therapy.
Assessment of fibrotic NASH ranges from noninvasive scores to percutaneous liver biopsy, but liver biopsy is invasive and limited by cost, sampling variability, and intrareader/interreader variability.
Noninvasive modalities to risk stratify fibrotic NASH include serum biomarkers, imaging, and algorithms combining both. The FibroScan-AST (FAST) composite score is based on the liver stiffness measure (LSM), controlled attenuation potential (CAP), and AST. At the cut-off of a FAST score ≥0.67, biopsy-proven fibrotic NASH (NAFLD with a histological NAFLD activity score [NAS] ≥4 and fibrosis ≥2) can be ruled in with 90% specificity.
A new predictive model was recently developed based on eight variables (age, BMI, HbA1c, history of type 2 diabetes, International normalized ratio (INR), AST, Gamma Glutamyl transferase (GGT), and platelet count). A composite score MAFLD Fibrosis Score (MFS) was calculated as: MFS = 0.078 × Age (year)-0.007363 × Platelet count (109/L) + 0.0146 × AST (U/L) + 0.007618 × GGT (U/L) + 6.673 × INR + 0.09833 × BMI (kg/m2) + 1.425 × type 2 diabetes (yes = 1, no = 0).
So, in this study, the investigators will try to evaluate the accuracy of the new emerging predictor MAFLD Fibrosis Score (MFS) vs AST- to-platelet ratio index (APRI) score, fibrosis-4 index (FIB-4) score, and NAFLD fibrosis score in the assessment of the fibrotic NASH in Egyptian NAFLD patients.
Detailed description
This study will be a cross-sectional study and will be carried out on 380 MAFLD patients attending to Tanta tropical medicine outpatient clinic, faculty of medicine. The start of the research will be in March 2024 to August 2024 or until collecting the cases.
Sample size The study will be carried on 382 patients according to the prevalence in Egypt 47.5% with confidence level 95% and margin of error 5 All the patients will be subjected to;
History taking:
Full history taking including:
- Personal history (name, age, sex, occupation, residence and marital state).
- Anthropometric measures: weight, length, BMI, Waist circumference.
- Complaint.
Investigations:
- Complete blood picture (CBC).
- Lipid profile (triglycerides, HDL, LDL, cholesterol level).
- Fasting Blood glucose level and or HBA1C.
- Liver functions (ALT, AST, INR, GGT, albumin, bilirubin).
- Viral markers and Anti-nuclear antibody (ANA). Data of radiological examination
- Fibroscan: Liver fibrosis and steatosis can be staged using Dimensional ultrasound transient elastography (TE).
- Ultrasound on abdomen and pelvis for evaluation of liver condition.
- Fibrotic NASH was diagnosed with FAST score with a cut-off ≥0.67, biopsy-proven fibrotic NASH (NAFLD with a histological NAFLD activity score [NAS] ≥4 and fibrosis ≥2). [8]
- MAFLD fibrosis score (MFS) is calculated using the formula:
MFS = 0.078 × Age (year)-0.007363 × Platelet count (109/L) + 0.0146 × AST (U/L) + 0.007618 × GGT (U/L) + 6.673 × INR + 0.09833 × BMI (kg/m2) + 1.425 × type 2 diabetes (yes = 1, no = 0).[9] - The FIB-4 index is calculated using the formula: FIB-4= Age (years)×AST(U/L)/ [platelet (109/L) ×ALT 1/2 (U/L)].
- NAFLD fibrosis score (NFS) is calculated using the formula: NFS = -1.675 + 0.037 × age (year) + 0.094 × BMI (kg/m2) + 1.13 × impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet count (×109/L) - 0.66 × albumin (g/dL).
Ethical considerations:
- A written informed consent form authorizing the collection of this data was signed by all patients.
- The study will be approved by the Ethical Committee of the Faculty of Medicine at Tanta University.
The risks to the participants and measures needed to minimize these risks:
- The privacy of the data of the patients will be maintained (the procedure will be discussed later in this protocol.
- Any unexpected risks appeared during the course of research will be cleared to the patients and the ethical committee on time.
Adequate provisions to maintain privacy of participants and confidentially of data are as follow:
- A code number for each patient will be used, symbols to the name and address will be kept in a special file.
- The investigators will hide the patients' names when the research is used.
- The investigators will use the results of the research only in scientific aim and not use it in other
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NAFLD patients attending Tanta Tropical Medicine outpatient clinic, faculty of medicine.
Key inclusion criteria (2 listed)
- Male or female patients older than 18 years.
- NAFLD Patients assessed by ultrasound, fibroscan.
Key exclusion criteria (8 listed)
- Patients aged < 18 years
- pregnant women.
- Excess alcohol intake (more than 30 g in men and 20 g in women).
- Viral hepatitis.
- Autoimmune hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of MFS in detecting Fibrotic NASH
Time frame: till August 2024
evaluation of accuracy of MAFLD Fibrosis Score (MFS) in the assessment of the fibrotic NASH in Egyptian patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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- Associated Fatty Liver Disease (MAFLD), 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of MFS in detecting Fibrotic NASH (time frame: till August 2024). 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 6 Mar 2025.