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

Completed

• Conditions: Hepatitis C, Acute; Diabetes; Hypertension
• Interventions: Diagnostic Test: BIOLINE HCV kits; Diagnostic Test: ACCU-CHEK kits; Diagnostic Test: ErKameter 3000 mercury manometer

• Registration Number: NCT03839979
• Lead Sponsor: Cairo University

Brief 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

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 Timeline

• Study Start: 2018-10-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-01-31
• Study First Submitted: 2019-02-09
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71975

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients younger than 18 years or older than 80 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCV positive patients	ACCU-CHEK kits	Patients tested positive for the hepatitis c virus antibodies by BIOLINE HCV kits.
HCV negative patients	BIOLINE HCV kits	Patients tested negative for the hepatitis c virus antibodies by BIOLINE HCV kits.
HCV negative patients	ErKameter 3000 mercury manometer	Patients tested negative for the hepatitis c virus antibodies by BIOLINE HCV kits.
HCV positive patients	BIOLINE HCV kits	Patients tested positive for the hepatitis c virus antibodies by BIOLINE HCV kits.
HCV positive patients	ErKameter 3000 mercury manometer	Patients tested positive for the hepatitis c virus antibodies by BIOLINE HCV kits.
HCV negative patients	ACCU-CHEK kits	Patients tested negative for the hepatitis c virus antibodies by BIOLINE HCV kits.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Egyptian Ministry of Health; 🇪🇬 Asyut, Egypt