Fatty Liver Among Employees at Banha University

NCT ID: NCT04367012

Last Updated: 2020-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 165 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-19
• Study Completion Date: 2019-08-25

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 ..

Conditions

Fatty Liver Disease; Fatty Infiltration

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

group 1 NAFLD and group 2 Non NAFLD

study from 20-60 years old.Subjects will be evaluated clinically by abdominal examination for evaluation of fatty liver and grades it into 3 grades .evaluation of fatty pancreas and grade it into 3 grades ,measuring blood pressure and physically by calculating body mass index (BMI) weight/height2

Abdominal Ultrasound

Intervention Type: OTHER

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

Group1 NAFLD & Group 2 Non NAFLD

As the study is randomized cross sectional , all subjects whom have fatty liver by abdominal ultrasound included in group 1 NAFLD , and whom do not have fatty liver by abdominal ultrasound included in group 2.both groups was age and sex matched

Abdominal Ultrasound

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

External Carotid Intimal thickness by Dopler

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

-

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Prof.Reda Mohamed Elbadawy

professor Gastroenterology,Hepatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha University

Banhā, , Egypt

Countries

Egypt

Other Identifiers

Prof.Reda Elbadawy

Identifier Type: OTHER

Identifier Source: secondary_id

Banha University

Identifier Type: -

Identifier Source: org_study_id