NCT03839979

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71,975

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

February 9, 2019

Last Update Submit

March 16, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • HCV diagnosis

    Detection of patients who are HCV positive or negative

    20 minutes

  • 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

  • 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

Study Arms (2)

HCV positive patients

Patients tested positive for the hepatitis c virus antibodies by BIOLINE HCV kits.

Diagnostic Test: BIOLINE HCV kitsDiagnostic Test: ACCU-CHEK kitsDiagnostic Test: ErKameter 3000 mercury manometer

HCV negative patients

Patients tested negative for the hepatitis c virus antibodies by BIOLINE HCV kits.

Diagnostic Test: BIOLINE HCV kitsDiagnostic Test: ACCU-CHEK kitsDiagnostic Test: ErKameter 3000 mercury manometer

Interventions

BIOLINE HCV kitsDIAGNOSTIC_TEST

We used BIOLINE HCV kits to detect the presence of HCV antibodies in stick blood samples of all recruited patients.

Also known as: diagnosis of viral hepatitis C
HCV negative patientsHCV positive patients
ACCU-CHEK kitsDIAGNOSTIC_TEST

For all patients, we measured random blood sugar levels by stick blood samples using ACCU-CHEK kits.

Also known as: measurement of blood sugar level
HCV negative patientsHCV positive patients

For all patients, we measured systolic blood pressure using ErKameter 3000 mercury manometer.

Also known as: blood pressure measurement
HCV negative patientsHCV positive patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Egyptian patients aged 18-80 years.

You may qualify if:

  • Egyptian citizens from 18 years to 80 years.

You may not qualify if:

  • Patients younger than 18 years or older than 80 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egyptian Ministry of Health

Asyut, 01234567, Egypt

Location

MeSH Terms

Conditions

Hepatitis CDiabetes MellitusHypertension

Interventions

Blood Pressure Determination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisPhysical Examination

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2019

First Posted

February 15, 2019

Study Start

October 1, 2018

Primary Completion

December 31, 2018

Study Completion

January 31, 2019

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

No individual data will be shared with other researchers.

Locations