NCT04367012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

October 10, 2019

Last Update Submit

July 17, 2020

Conditions

Keywords

Insulin resistant (IR)

Outcome Measures

Primary Outcomes (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

    15 month

Secondary Outcomes (1)

  • fatty pancreas among employees at Banha University as compication for fatty liver

    15 months

Other Outcomes (2)

  • Atherosclerosis among fatty liver employees at Banha University

    15 month

  • The associated 7 risk factors

    15 month

Study Arms (2)

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

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

Other: Abdominal Ultrasound

Interventions

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

Also known as: External Carotid Intimal thickness by Dopler
Group1 NAFLD & Group 2 Non NAFLDgroup 1 NAFLD and group 2 Non NAFLD

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University

Banhā, 1351, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor Gastroenterology,Hepatology

Study Record Dates

First Submitted

October 10, 2019

First Posted

April 29, 2020

Study Start

April 19, 2018

Primary Completion

February 20, 2019

Study Completion

August 25, 2019

Last Updated

July 20, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

The results of the study

Locations