Hepatitis C, AcuteNCT03839979
HCV Viral Hepatitis, Blood Sugar Level and Systolic Blood Pressure in Egypt
An observational study of Hepatitis C, Acute and Diabetes, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Acute, Diabetes, Hypertension
- What is being tested?
- BIOLINE HCV kits, ACCU-CHEK kits and ErKameter 3000 mercury manometer
- How many people
- 71,975 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 31 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Egyptian patients aged 18-80 years.
Who may be able to join
- Egyptian citizens from 18 years to 80 years.
Who cannot join
- Patients younger than 18 years or older than 80 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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???
- Conditions
- Hepatitis C, Acute, Diabetes, Hypertension
- Being tested
- BIOLINE HCV kits, ACCU-CHEK kits, ErKameter 3000 mercury manometer
- Medical subject headings
- Hepatitis C, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOLINE HCV kitsDiagnostic test
Also called diagnosis of viral hepatitis C
We used BIOLINE HCV kits to detect the presence of HCV antibodies in stick blood samples of all recruited patients.
ACCU-CHEK kitsDiagnostic test
Also called measurement of blood sugar level
For all patients, we measured random blood sugar levels by stick blood samples using ACCU-CHEK kits.
ErKameter 3000 mercury manometerDiagnostic test
Also called blood pressure measurement
For all patients, we measured systolic blood pressure using ErKameter 3000 mercury manometer.
| Study group | Role | What they receive |
|---|---|---|
| HCV positive patients | Patients tested positive for the hepatitis c virus antibodies by BIOLINE HCV kits. Receives: Diagnostic Test: BIOLINE HCV kits; Diagnostic Test: ACCU-CHEK kits; Diagnostic Test: ErKameter 3000 mercury manometer | |
| HCV negative patients | Patients tested negative for the hepatitis c virus antibodies by BIOLINE HCV kits. Receives: Diagnostic Test: BIOLINE HCV kits; Diagnostic Test: ACCU-CHEK kits; Diagnostic Test: ErKameter 3000 mercury manometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV diagnosis
Detection of patients who are HCV positive or negative
Measured: 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
Measured: 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
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Oct 2018
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, AcuteStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 71,975 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Wageh Mohareb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839979
- Sponsor's protocol ID
- One million healthy citizen 18
- Status last verified
- Mar 2021
- First submitted
- 9 Feb 2019
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between HCV Viral Hepatitis, Blood Sugar Level and Systolic Blood Pressure in the Egyptian Population
- ClinicalTrials.gov ID
- NCT03839979
- Acronym / sponsor ID
- One million healthy citizen 18
- Conditions
- Hepatitis C, Acute, Diabetes, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71,975 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV positive patients | – | Diagnostic Test: BIOLINE HCV kits, Diagnostic Test: ACCU-CHEK kits, Diagnostic Test: ErKameter 3000 mercury manometerPatients tested positive for the hepatitis c virus antibodies by BIOLINE HCV kits. |
| HCV negative patients | – | Diagnostic Test: BIOLINE HCV kits, Diagnostic Test: ACCU-CHEK kits, Diagnostic Test: ErKameter 3000 mercury manometerPatients tested negative for the hepatitis c virus antibodies by BIOLINE HCV kits. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Egyptian patients aged 18-80 years.
Key inclusion criteria (1 listed)
- Egyptian citizens from 18 years to 80 years.
Key exclusion criteria (1 listed)
- Patients younger than 18 years or older than 80 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOLINE HCV kitsAlso: diagnosis of viral hepatitis CWe used BIOLINE HCV kits to detect the presence of HCV antibodies in stick blood samples of all recruited patients. | Diagnostic test | HCV negative patients, HCV positive patients |
| ACCU-CHEK kitsAlso: measurement of blood sugar levelFor all patients, we measured random blood sugar levels by stick blood samples using ACCU-CHEK kits. | Diagnostic test | HCV negative patients, HCV positive patients |
| ErKameter 3000 mercury manometerAlso: blood pressure measurementFor all patients, we measured systolic blood pressure using ErKameter 3000 mercury manometer. | Diagnostic test | HCV negative patients, HCV positive patients |
Primary outcome
HCV diagnosis
Time frame: 20 minutes
Detection of patients who are HCV positive or negative
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No. No individual data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Acute and Diabetes, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV diagnosis (time frame: 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.