Screening for Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) at Al-Rajhy Hospital Nutrition Clinic. Assiut, Egypt

April 23, 2021 updated by: Yusuf Salah-eldin Amry Ahmad, Assiut University

Screening for Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) at Al-Rajhy Hospital Nutrition Clinic

Primary outcome Screen for MAFLD among patients attending to the Nutrition clinic in Al Rajhi hospital.

Secondary outcome

  • Determining the degrees of fibrosis and steatosis in patients with MAFLD
  • Determining the rate of obesity, diabetes mellitus (DM), hypertension (HTN), hyperlipidemia in patients with MAFLD.
  • Determining the rate of patients with other associated chronic liver disease (CLD).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Metabolic dysfunction-associated fatty liver disease (MAFLD) formly called non alcoholic fatty liver disease (NAFLD) was defined as the presence of macrovesicular steatosis in ≥5% of hepatocytes in individuals who consume little or no alcohol. NAFLD was divided into two major subtypes: nonalcoholic fatty liver, and Non alcoholic steatohepatitis (NASH).

It is now believed that MAFLD is due to state of systemic metabolic dysfunction and is perceived as standalone disease that warrants positive diagnosis rather than simply a disease of exclusion. MAFLD affects about quarter of the world's population and it is now considered a public health issue.

Real time ultrasound (US) scanning is accepted as the first line imaging investigation in patients with suspected liver disorders. In spite insufficient sensitivity to detect liver inflammation and fibrosis, it demonstrates a good correlation with histological finding of fatty infiltration.

Another tool used for detection of fatty liver is fatty liver index (FLI) which is an algorithm based on waist circumference, body mass index (BMI), triglyceride, and gamma-glutamyl-transferase (GGT). A FLI < 30 (negative likelihood ratio = 0.2) rules out and a FLI ≥ 60 (positive likelihood ratio = 4.3) rules in fatty liver. FLI had an accuracy of 0.84 (95% confidence interval (CI) 0.81-0.87) in detecting fatty liver.

Haung X, et al, 2015 found that FLI achieves a high sensitivity of 79.89% and a specificity of 71.51% for diagnosis of NAFLD.

TE (transient elastography) is a non-invasive ultrasound-based method that uses shear wave velocity to assess tissue (e.g., liver) stiffness. It has been applied in medical practice under the name FibroScan®.

Based on the physical characteristics (velocity and intensity attenuation) of the shear wave, the acquired data in the examination are processed and displayed on the screen as the liver stiffness measurement (LSM) and controlled attenuation parameter (CAP).

LSM values range from 1.5 to 75 kPa; lower values indicate a more elastic liver. CAP values range from 100 to 400 dB/m, and higher numbers indicate more pronounced steatosis.

A meta-analysis in 2014 has indicated that TE is excellent in diagnosing F ≥ 3 (85% sensitivity, 82% specificity) and F4 (92% sensitivity, 92% specificity), and it has a moderate accuracy for F ≥ 2 in NAFLD patients.

According to various studies, compared to liver biopsy, CAP is useful in the detection of S ≥ 1, S ≥ 2, and S3 (where S0 indicates no steatosis, to S3, which indicates the highest level of steatosis steatosis) because of its good sensitivity and specificity; however, the exact cut-off values remain to be defined.

Sample size estimation:

To assess the prevalence of MAFLD in, a prospective cross-sectional study was conducted. Based on previous studies (24), the expected frequency of MAFLD in Egypt is 37%. For a two-sided 95% confidence interval for a single proportion using the large sample normal approximation that will extend 5 % from the expected proportion, a sample size of 360 participant will be recruited. The sample will be equally represented from urban and rural areas. Sample size estimation was performed by Epi Info statistical package (Dean A, 1990).

Dean A (1990). Epi Info, Version 5.01. US Department of Health and Human Services, Public Health Service, Centers for Disease Control; 1990.

Statistical methods Data management and analysis will be performed using Statistical Package for Social Sciences (SPSS) vs. 25. Numerical data were summarized using means and standard deviations or medians, interquartile ranges and/or ranges, as appropriate. Categorical data were summarized as numbers and percentages. Estimates of the frequency of different grade of severity of NAFLD in the entire sample and will be done using the numbers and percentages. Numerical data were explored for normality using Kolmogrov-Smirnov test and Shapiro-Wilk test. The severity of fatty liver will be related to different serological risk factors of metabolic syndrome and diseases progression.

Chi square or Fisher's tests will be used to compare between the groups with respect to categorical data, as appropriate. Comparisons between two groups for normally distributed numeric variables will be done using the Student's t-test while for non-normally distributed numeric variables, comparisons will be done by Mann-Whitney test. Comparisons between more than 2 groups will be performed by the one analysis of variance (ANOVA) for normally distributed variables and Kruskal-Wallis for non-normally distributed variables, then followed by post hoc if needed. To measure the strength of association between the normally distributed numerical measurements, Pearson's correlation coefficients will be computed. Spearman's correlation coefficients will be calculated for non-normally distributed variables. All tests are two-sided. P-values < 0.05 is considered significant.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

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

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18-80 years

Exclusion Criteria:

  • Pregnant females.
  • Patients who will refuse to participate in the study.

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screen for MAFLD among patients attending to the Nutrition clinic in Al Rajhi hospital
Time Frame: baseline

Screening will be done according to new criteria set by Eslam M, et al, 2020, Patients with detected fatty liver by ultrasound will undergo an evaluation for the BMI and fasting and post prandial blood glucose levels. Patients with with BMI >25 kg/m2 or type two diabetes mellitus (DM) will be diagnosed to have MAFLD. Patients with BMI < 25 kg/m2 and normal sugar curve will be subjected to tests to detect metabolic abnormalities with the presence of at least two metabolic risk abnormalities, the subject will be diagnosed as MAFLD.

Eventually the percentage of patients diagnosed as MAFLD will be calculated among this random sample
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determining the number of patients diagnosed as MAFLD and degree of fibrosis and steatosis in each one.
Time Frame: baseline
Fibro scan with CAP to all patients meeting criteria of MAFLD
baseline
Determining the rate of patients with other associated chronic liver disease(CLD)
Time Frame: baseline
Hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen will be done for all participants and history of any CLD
baseline
Determining the rate of obesity, DM, HTN, hyperlipidemia in patients with MAFLD
Time Frame: baseline
.Through history, clinical examination and lab tests.
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Sherif Kamel, professor, Assiut University
  • Study Director: Mohammed Medhat, Lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 23, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAFLD Assiut

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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