Clinical trial NCT04367012: Fatty Liver Among Employees at Banha University
Official title: Prevelance of Non Alcoholic Fatty Liver Disease,Its Complications Among Employees at Banha University Hospital,Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatty Liver Disease
Fatty Infiltration
Keywords: Insulin resistant (IR)
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 165
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both males and females sex aged from 20-60 years old agree was included in the study after written consent.

Brief 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.

Detailed 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 ..

Eligibility criteria: 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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Primary outcomes:
measure: prevalence of fatty liver among employees at Banha University
timeFrame: 15 month
Secondary outcomes:
measure: fatty pancreas among employees at Banha University as compication for fatty liver
timeFrame: 15 months
Other outcomes:
measure: Atherosclerosis among fatty liver employees at Banha University
timeFrame: 15 month
measure: The associated 7 risk factors
timeFrame: 15 month
Locations:
city: Banha
country: Egypt
facility: Benha University
Study officials:
References: