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

Primary Purpose

Steatohepatitis, Nonalcoholic

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Steatohepatitis, Nonalcoholic focused on measuring MAFLD

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 18-80 years

Exclusion Criteria:

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 20, 2021
    Last Updated
    April 23, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04861012
    Brief Title
    Screening for Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) at Al-Rajhy Hospital Nutrition Clinic. Assiut, Egypt
    Official Title
    Screening for Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) at Al-Rajhy Hospital Nutrition Clinic
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Steatohepatitis, Nonalcoholic
    Keywords
    MAFLD

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    360 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound
    Other Intervention Name(s)
    Fibroscan
    Intervention Description
    All subjects initially will be subjected to abdominal ultrasound, and if fatty liver is detected fibroscan will be done
    Primary Outcome Measure Information:
    Title
    Screen for MAFLD among patients attending to the Nutrition clinic in Al Rajhi hospital
    Description
    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
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    determining the number of patients diagnosed as MAFLD and degree of fibrosis and steatosis in each one.
    Description
    Fibro scan with CAP to all patients meeting criteria of MAFLD
    Time Frame
    baseline
    Title
    Determining the rate of patients with other associated chronic liver disease(CLD)
    Description
    Hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen will be done for all participants and history of any CLD
    Time Frame
    baseline
    Title
    Determining the rate of obesity, DM, HTN, hyperlipidemia in patients with MAFLD
    Description
    .Through history, clinical examination and lab tests.
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age: 18-80 years Exclusion Criteria: Pregnant females. Patients who will refuse to participate in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yusuf Amry, Resident
    Phone
    00201068160066
    Email
    yusufamry@rocketmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Magda Hassan, Professor
    Phone
    00201066900939
    Email
    Magda_sh@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sherif Kamel, Professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Mohammed Medhat, Lecturer
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

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

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