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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03839979
Other study ID # One million healthy citizen 18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date January 31, 2019

Study information

Verified date March 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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???


Recruitment information / eligibility

Status Completed
Enrollment 71975
Est. completion date January 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria - Egyptian citizens from 18 years to 80 years. Exclusion Criteria: - Patients younger than 18 years or older than 80 years

Study Design


Intervention

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.
ACCU-CHEK kits
For all patients, we measured random blood sugar levels by stick blood samples using ACCU-CHEK kits.
ErKameter 3000 mercury manometer
For all patients, we measured systolic blood pressure using ErKameter 3000 mercury manometer.

Locations

Country Name City State
Egypt Egyptian Ministry of Health Asyut

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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