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Fatty Liver DiseasefattyliverNCT04367012

Fatty Liver Among Employees at Banha University

An observational study of Fatty Liver Disease and Fatty Infiltration, run by Benha University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Fatty Liver Disease, Fatty Infiltration
What is being tested?
Abdominal Ultrasound
How many people
165 participants
Where
1 siteEgypt
Study dates
19 Apr 2018to 25 Aug 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Both males and females sex aged from 20-60 years old agree was included in the study after written consent.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Benha University

    Banhā, 1351

Other trials in Egypt

About this study

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

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.

Read the 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 ..
Being tested
Abdominal Ultrasound
Keywords
Insulin resistant (IR)
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abdominal UltrasoundOther

    Also called External Carotid Intimal thickness by Dopler

    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

Study groups in NCT04367012
Study groupRoleWhat they receive
group 1 NAFLD and group 2 Non NAFLDstudy 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
Receives: Other: Abdominal Ultrasound
Group1 NAFLD & Group 2 Non NAFLDAs 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
Receives: Other: Abdominal Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 15 month

Secondary outcomes (1)
  1. 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

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2020
  2. Study start19 Apr 2018
  3. Primary completion20 Feb 2019
  4. Study completion25 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Cross-sectional
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04367012
Sponsor's protocol ID
Banha University
Other IDs
Prof.Reda Elbadawy
Acronym
fattyliver
Status last verified
Jul 2020
First submitted
10 Oct 2019
Last updated
20 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The results of the study

Questions about this trial

What is this clinical trial studying?

An observational study of Fatty Liver Disease and Fatty Infiltration, run by Benha University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

prevalence of fatty liver among employees at Banha University (time frame: 15 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.

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