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.
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.
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 ..
- Conditions
- Fatty Liver Disease, Fatty Infiltration
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Abdominal Ultrasound | |
| 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 Receives: Other: Abdominal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted29 Apr 2020
- Study start19 Apr 2018
- Primary completion20 Feb 2019
- Study completion25 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.Reda Mohamed Elbadawy, Benha University
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevelance of Non Alcoholic Fatty Liver Disease,Its Complications Among Employees at Banha University Hospital,Egypt
- ClinicalTrials.gov ID
- NCT04367012
- Acronym / sponsor ID
- fattyliver / Banha University
- Conditions
- Fatty Liver Disease, Fatty Infiltration
- Keywords
- Insulin resistant (IR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 25 Aug 2019 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ..
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 NAFLD and group 2 Non NAFLD | – | Other: Abdominal Ultrasoundstudy 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 |
| Group1 NAFLD & Group 2 Non NAFLD | – | Other: Abdominal UltrasoundAs 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Both males and females sex aged from 20-60 years old agree was included in the study after written consent.
Key inclusion criteria (1 listed)
- All subjects was appear healthy with and without DM or hypertension ,also obese or non -
Key exclusion criteria (2 listed)
- Any chronic liver disease , Hepatitis C virus patients (HCV) , Hepatitis B virus patients(HBV) and autoimmune liver disease
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal UltrasoundAlso: External Carotid Intimal thickness by Doplerpatient 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 | Other | Group1 NAFLD & Group 2 Non NAFLD, group 1 NAFLD and group 2 Non NAFLD |
Primary outcome
prevalence of fatty liver among employees at Banha University
Time frame: 15 month
Grades of fatty liver was measured as 1,2,3 according to the relation of echogencity beween liver and Right kidney
1 secondary outcome
fatty pancreas among employees at Banha University as compication for fatty liver
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Individual participant dataSharing planned: No. The results of the study
Related trials for Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.