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

Steatohepatitis, Nonalcoholic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04861012
• Other study ID #: MAFLD Assiut
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: December 2022

Study information

• Verified date: April 2021
• Source: Assiut University
• Contact: Yusuf Amry, Resident
• Phone: 00201068160066
• Email: yusufamry[@]rocketmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age: 18-80 years

Exclusion Criteria:

• Pregnant females.

• Patients who will refuse to participate in the study.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Steatohepatitis, Nonalcoholic

Intervention

Device:
• Ultrasound
All subjects initially will be subjected to abdominal ultrasound, and if fatty liver is detected fibroscan will be done

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (23)

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Afdhal NH. Fibroscan (transient elastography) for the measurement of liver fibrosis. Gastroenterol Hepatol (N Y). 2012 Sep;8(9):605-7. — View Citation

Bedogni G, Bellentani S, Miglioli L, Masutti F, Passalacqua M, Castiglione A, Tiribelli C. The Fatty Liver Index: a simple and accurate predictor of hepatic steatosis in the general population. BMC Gastroenterol. 2006 Nov 2;6:33. — View Citation

Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008 May;48(5):835-47. doi: 10.1016/j.jhep.2008.02.008. Epub 2008 Feb 26. Review. — View Citation

Chan WK, Nik Mustapha NR, Mahadeva S. Controlled attenuation parameter for the detection and quantification of hepatic steatosis in nonalcoholic fatty liver disease. J Gastroenterol Hepatol. 2014;29(7):1470-6. doi: 10.1111/jgh.12557. — View Citation

de Lédinghen V, Vergniol J, Foucher J, Merrouche W, le Bail B. Non-invasive diagnosis of liver steatosis using controlled attenuation parameter (CAP) and transient elastography. Liver Int. 2012 Jul;32(6):911-8. doi: 10.1111/j.1478-3231.2012.02820.x. — View Citation

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Huang X, Xu M, Chen Y, Peng K, Huang Y, Wang P, Ding L, Lin L, Xu Y, Chen Y, Lu J, Wang W, Bi Y, Ning G. Validation of the Fatty Liver Index for Nonalcoholic Fatty Liver Disease in Middle-Aged and Elderly Chinese. Medicine (Baltimore). 2015 Oct;94(40):e1682. doi: 10.1097/MD.0000000000001682. — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline
Secondary	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	baseline
Secondary	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	baseline
Secondary	Determining the rate of obesity, DM, HTN, hyperlipidemia in patients with MAFLD	.Through history, clinical examination and lab tests.	baseline