Fatty Liver Among Employees at Banha University

Fatty Liver Disease Clinical Trial

— fattyliver  

Official title:

Prevelance of Non Alcoholic Fatty Liver Disease,Its Complications Among Employees at Banha University Hospital,Egypt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367012
• Other study ID #: Banha University
• Secondary ID: Prof.Reda Elbada
• Status: Completed
• Start date: April 19, 2018
• Est. completion date: August 25, 2019

Study information

• Verified date: July 2020
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This was cross sectional study at Banha University Hospital among employees. Age of the subjects from 20-60 years old both males and females .All investigations done plus abdominal ultrasound for grading of fatty liver and dopler for carotid intima media thickness.

Description:

This cross-sectional study was conducted on employees working for the Benha University Hospitals, Qalubeyia Governorate, Egypt. The study population comprised both male and female employees (20 to 60 years old) with no history of viral hepatitis(HBV,HCV) and autoimmune-liver diseases such as primary sclerosing cholangitis and primary billiary cirrhosis . The field work was carried out from September 2018 to March 2019.

This study was approved by the Research Ethics Committee in Benha Faculty of Medicine. An informed consent (in Arabic language) was obtained from all participants. It included all details about the study (title, objectives, methods, expected benefits and risks, and confidentiality of data).

Subjects:

The sample size for the study was calculated according to the following equation 1:

"Sample size" = (〖Z_(1-∝/2)〗^(2 ) P(1-P))/d^2 Where

Z 1-α/2 = standard normal deviate; (at 5% type I error (P<0.05) it is 1.96). P=expected proportion in population based on previous studies 2. d= absolute error or precision (0.05). The total number of the study participants was 165 subjects, who confirm with the inclusion criteria and agreed to participate in the study. These were selected by the systematic random sampling technique.

Data collection tools:

An arranged interview with every study participant was carried out at the Hepatology and Gastrointestinal Department of the Benha University Hospital. All the study participants were exposed to full history taking and clinical examination. Venous blood samples after fasting for 10 hours were collected for complete blood counting, and the assessment of fasting blood glucose, fasting insulin, HOMA-IR test by soecific equation , liver functions testing (ALT,AST ,GGT &Alk.Phosphatase) . kidney functions testing(Serum Urea & Serum Creatinine ) and lipid profile include (serum cholesterol, very low density and high density lipoprotein. Assessment of Liver Fatty Acid Binding Protein (L-FABP), , was carried out using ELIZA. Abdominal Ultrasound for grading of fatty liver from grade 1 to grade 3 according to the comparison with echogencity of right kidney and Doppler on external carotid artery were performed to measure the the intima media thickness.

the different study groups were carried out using the Chi-square test (X2) and the Fisher Exact test (FET) to compare proportions as appropriate. The Student t-test (t) and the Mann-Whitney test (MW) were used to compare two groups of quantitative data regarding parametric and non-parametric data, respectively. While the Kruskal Wallis test and One-Way Analysis Of Variance (ANOVA; F) were used to compare more than two groups, followed by post-hock testing using the Bonferroni method to detect differences in pairs. Spearman correlation coefficient (rho) and Pearson correlation coefficient (r) were used to assess the correlation between the studies parameters as appropriate. the diagnostic performance of L-FAB, HOMA-IR and CIT for NAFLD was examined and the best cut-off and the corresponding Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value and Area Under the Curve were estimated. Statistical significance was accepted at P value <0.05 (S).

The statistical analysis was conducted using STATA/SE version 11.2 for Windows (STATA corporation, College Station, Texas).

All the peoples from age 20-60 years old both males and females will be included , apparently healthy either obese or not from banha university employees and students.

They will be evaluated clinically and examined as follow :

• Blood pressure , body mass index(BMI)=heigh/weigh2

• Invesigations as follow , complete blood count(CBC), fasting blood sugar ,glycosyated haemoglobin (HbA1c),Liver function tests including alaninie aminotransferease (ALT) ,aspartateaminotransferase(AST),gamma glutamyl transpeptidase (GGT),alkaline phosphatase ,serum bilirubin, and serum albumin.

lipid profile including (cholesterol,triglycerides,HDL,C and LDL).

• Serum insulin level for calculating insulin resistance (IR) Homostasis Model Assay for Insulin Resistant(HOMA-IR) was assessed using the given mathematical equation; HOMA-IR ¼ fasting insulin (mU/ml) fasting plasma glucose (mmol/l)/22.5 . A HOMA value of 2.18, signifies IR Fatty Acid Binding protein1 (FABP1)

• FABP1 was evaluated after the patient fasting 8 hours by the enzyme-linked immunosorbent assay (ELISA) according to George Haltern ,et al 2010 and the deviation from the normal will be correlated with other investigations and clinical manifestations of the subjects.

• Abdominal Ultrasound was done for grading of fatty liver , to 3 grades from grade 1 to grade3 in comparison to right kidney and diphragm . .

• Carotid Intimal Media Thickenss(CIMT) measured for extracranial portion of Carotid artey by Colour Dopler by measure while the patiet in recumbancy at45 degree and the probe must be in angle less than 90 degree to get the correct results ..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: August 25, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

All subjects was appear healthy with and without DM or hypertension ,also obese or non -

Exclusion Criteria:

Any chronic liver disease , Hepatitis C virus patients (HCV) , Hepatitis B virus patients(HBV) and autoimmune liver disease

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Related Conditions & MeSH terms

• Fatty Infiltration
• Fatty Liver
• Fatty Liver Disease
• Liver Diseases

Intervention

Other:
• Abdominal Ultrasound
patient in supine position and external carotid artery was examined to meausre the intima using US .Machine GE logic FB inear probe10Mhz.and intimal media thickness mean =10mm

Locations

Country	Name	City	State
Egypt	Benha University	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Atherosclerosis among fatty liver employees at Banha University	Measure the carotid intima media thickness if more than 6mm it will considered atherosclerosis	15 month
Other	The associated 7 risk factors	Age>45 years old,DM ,Hypertension ,Urban area,GGT ,ALP and BMI>30kg/m2	15 month
Primary	prevalence of fatty liver among employees at Banha University	Grades of fatty liver was measured as 1,2,3 according to the relation of echogencity beween liver and Right kidney	15 month
Secondary	fatty pancreas among employees at Banha University as compication for fatty liver	Fatty Pancreas was measured by grades 1,2,3 according to the echogencity of retroperitoneal fatt as well as left kidney and liver echogencity	15 months