HCV Viral Hepatitis, Blood Sugar Level and Systolic Blood Pressure in Egypt

March 16, 2021 updated by: Mina Wageh Mohareb, Cairo University

Association Between HCV Viral Hepatitis, Blood Sugar Level and Systolic Blood Pressure in the Egyptian Population

An observational double-blind cohort study that examined the association between HCV viral hepatitis, blood sugar level and systolic blood pressure in the Egyptian population

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

a cohort study on greater than 70000 Egyptian patients had been conducted. for all patients,1- we detected the Hepatitis C Virus (HCV) RNA antigens ( hepatitis C virus)presence using BIOLINE HCV kits( qualitative test for diagnosis of hepatitis C virus in the blood), For all positive patients, confirmatory rapid screening test was performed and all patients who tested positive twice underwent a qPCR test using QIAampMinElute Virus Spin kit (Thermo Fisher Scientific, Waltham, MA, USA) performed according to the manufacturer's recommended protocol.

2- Investigators measured blood sugar levels for each patient using ACCU-CHEK kits(finger stick sugar level measurement) 3- Measured systolic blood pressure for each patient was measured using mercury meters.

4-for all patients investigators obtained full medical history regarding the presence or absence of chronic diabetes, chronic hypertension, coronary artery disease, kidney impairment with dialysis or chronic obstructive pulmonary disease.

5- for all patients investigators listed age, gender, and body mass index. 66121 patients were negative for HCV and 4852 were positive for HCV. Investigators measured the association between HCV presence, high blood sugar levels and high systolic blood pressure.

It is supposed that this is the largest study in the world that examined both associations.

In a word, this study was responding to a specific question: is hepatitis c virus presence is associated with high blood pressure or high sugar level or both or not associated???

Study Type

Observational

Enrollment (Actual)

71975

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Asyut, Egypt, 01234567
        • Egyptian Ministry of Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Egyptian patients aged 18-80 years.

Description

Inclusion Criteria

  • Egyptian citizens from 18 years to 80 years.

Exclusion Criteria:

  • Patients younger than 18 years or older than 80 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCV positive patients
Patients tested positive for the hepatitis c virus antibodies by BIOLINE HCV kits.
Diagnostic test: BIOLINE HCV kits
We used BIOLINE HCV kits to detect the presence of HCV antibodies in stick blood samples of all recruited patients.
Other Names:
  • diagnosis of viral hepatitis C
Diagnostic test: ACCU-CHEK kits
For all patients, we measured random blood sugar levels by stick blood samples using ACCU-CHEK kits.
Other Names:
  • measurement of blood sugar level
Diagnostic test: ErKameter 3000 mercury manometer
For all patients, we measured systolic blood pressure using ErKameter 3000 mercury manometer.
Other Names:
  • blood pressure measurement
HCV negative patients
Patients tested negative for the hepatitis c virus antibodies by BIOLINE HCV kits.
Diagnostic test: BIOLINE HCV kits
We used BIOLINE HCV kits to detect the presence of HCV antibodies in stick blood samples of all recruited patients.
Other Names:
  • diagnosis of viral hepatitis C
Diagnostic test: ACCU-CHEK kits
For all patients, we measured random blood sugar levels by stick blood samples using ACCU-CHEK kits.
Other Names:
  • measurement of blood sugar level
Diagnostic test: ErKameter 3000 mercury manometer
For all patients, we measured systolic blood pressure using ErKameter 3000 mercury manometer.
Other Names:
  • blood pressure measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV diagnosis
Time Frame: 20 minutes
Detection of patients who are HCV positive or negative
20 minutes
Measurement of blood sugar level in mg/dl
Time Frame: 1 minute
Detection of the percentage of patients with high blood sugar level in HCV positive or negative patients
1 minute
Measurement of systolic blood pressure in mmHg
Time Frame: 1 minute
Detection of the percentage of patients with high systolic blood pressure in HCV positive or negative patients
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

February 9, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • One million healthy citizen 18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No individual data will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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