- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03839979
HCV Viral Hepatitis, Blood Sugar Level and Systolic Blood Pressure in Egypt
Association Between HCV Viral Hepatitis, Blood Sugar Level and Systolic Blood Pressure in the Egyptian Population
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Asyut, Egypt, 01234567
- Egyptian Ministry of Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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HCV positive patients
Patients tested positive for the hepatitis c virus antibodies by BIOLINE HCV kits.
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We used BIOLINE HCV kits to detect the presence of HCV antibodies in stick blood samples of all recruited patients.
Other Names:
For all patients, we measured random blood sugar levels by stick blood samples using ACCU-CHEK kits.
Other Names:
For all patients, we measured systolic blood pressure using ErKameter 3000 mercury manometer.
Other Names:
|
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HCV negative patients
Patients tested negative for the hepatitis c virus antibodies by 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:
For all patients, we measured random blood sugar levels by stick blood samples using ACCU-CHEK kits.
Other Names:
For all patients, we measured systolic blood pressure using ErKameter 3000 mercury manometer.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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HCV diagnosis
Time Frame: 20 minutes
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Detection of patients who are HCV positive or negative
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20 minutes
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Measurement of blood sugar level in mg/dl
Time Frame: 1 minute
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Detection of the percentage of patients with high blood sugar level in HCV positive or negative patients
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1 minute
|
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Measurement of systolic blood pressure in mmHg
Time Frame: 1 minute
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Detection of the percentage of patients with high systolic blood pressure in HCV positive or negative patients
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1 minute
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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