<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03839979</url>
  </required_header>
  <id_info>
    <org_study_id>One million healthy citizen 18</org_study_id>
    <nct_id>NCT03839979</nct_id>
  </id_info>
  <brief_title>HCV Viral Hepatitis, Blood Sugar Level and Systolic Blood Pressure in Egypt</brief_title>
  <official_title>Association Between HCV Viral Hepatitis, Blood Sugar Level and Systolic Blood Pressure in the Egyptian Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      An observational double-blind cohort study that examined the association between HCV viral&#xD;
      hepatitis, blood sugar level and systolic blood pressure in the Egyptian population&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      a cohort study on greater than 70000 Egyptian patients had been conducted. for all&#xD;
      patients,1- we detected the Hepatitis C Virus (HCV) RNA antigens ( hepatitis C virus)presence&#xD;
      using BIOLINE HCV kits( qualitative test for diagnosis of hepatitis C virus in the blood),&#xD;
      For all positive patients, confirmatory rapid screening test was performed and all patients&#xD;
      who tested positive twice underwent a qPCR test using QIAampMinElute Virus Spin kit (Thermo&#xD;
      Fisher Scientific, Waltham, MA, USA) performed according to the manufacturer's recommended&#xD;
      protocol.&#xD;
&#xD;
      2- Investigators measured blood sugar levels for each patient using ACCU-CHEK kits(finger&#xD;
      stick sugar level measurement) 3- Measured systolic blood pressure for each patient was&#xD;
      measured using mercury meters.&#xD;
&#xD;
      4-for all patients investigators obtained full medical history regarding the presence or&#xD;
      absence of chronic diabetes, chronic hypertension, coronary artery disease, kidney impairment&#xD;
      with dialysis or chronic obstructive pulmonary disease.&#xD;
&#xD;
      5- for all patients investigators listed age, gender, and body mass index. 66121 patients&#xD;
      were negative for HCV and 4852 were positive for HCV. Investigators measured the association&#xD;
      between HCV presence, high blood sugar levels and high systolic blood pressure.&#xD;
&#xD;
      It is supposed that this is the largest study in the world that examined both associations.&#xD;
&#xD;
      In a word, this study was responding to a specific question: is hepatitis c virus presence is&#xD;
      associated with high blood pressure or high sugar level or both or not associated???&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>HCV diagnosis</measure>
    <time_frame>20 minutes</time_frame>
    <description>Detection of patients who are HCV positive or negative</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of blood sugar level in mg/dl</measure>
    <time_frame>1 minute</time_frame>
    <description>Detection of the percentage of patients with high blood sugar level in HCV positive or negative patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of systolic blood pressure in mmHg</measure>
    <time_frame>1 minute</time_frame>
    <description>Detection of the percentage of patients with high systolic blood pressure in HCV positive or negative patients</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">71975</enrollment>
  <condition>Hepatitis C, Acute</condition>
  <condition>Diabetes</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>HCV positive patients</arm_group_label>
    <description>Patients tested positive for the hepatitis c virus antibodies by BIOLINE HCV kits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HCV negative patients</arm_group_label>
    <description>Patients tested negative for the hepatitis c virus antibodies by BIOLINE HCV kits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>BIOLINE HCV kits</intervention_name>
    <description>We used BIOLINE HCV kits to detect the presence of HCV antibodies in stick blood samples of all recruited patients.</description>
    <arm_group_label>HCV negative patients</arm_group_label>
    <arm_group_label>HCV positive patients</arm_group_label>
    <other_name>diagnosis of viral hepatitis C</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ACCU-CHEK kits</intervention_name>
    <description>For all patients, we measured random blood sugar levels by stick blood samples using ACCU-CHEK kits.</description>
    <arm_group_label>HCV negative patients</arm_group_label>
    <arm_group_label>HCV positive patients</arm_group_label>
    <other_name>measurement of blood sugar level</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ErKameter 3000 mercury manometer</intervention_name>
    <description>For all patients, we measured systolic blood pressure using ErKameter 3000 mercury manometer.</description>
    <arm_group_label>HCV negative patients</arm_group_label>
    <arm_group_label>HCV positive patients</arm_group_label>
    <other_name>blood pressure measurement</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Egyptian patients aged 18-80 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Egyptian citizens from 18 years to 80 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years or older than 80 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Egyptian Ministry of Health</name>
      <address>
        <city>Asyut</city>
        <zip>01234567</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>February 9, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mina Wageh Mohareb</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No individual data will be shared with other researchers.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03839979
org study id: One million healthy citizen 18
nct id: NCT03839979
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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
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???
observational model: Other
time perspective: Retrospective
measure: HCV diagnosis
time frame: 20 minutes
description: Detection of patients who are HCV positive or negative
measure: Measurement of blood sugar level in mg/dl
time frame: 1 minute
description: Detection of the percentage of patients with high blood sugar level in HCV positive or negative patients
measure: Measurement of systolic blood pressure in mmHg
time frame: 1 minute
description: Detection of the percentage of patients with high systolic blood pressure in HCV positive or negative patients
arm group label: HCV positive patients
description: Patients tested positive for the hepatitis c virus antibodies by BIOLINE HCV kits.
arm group label: HCV negative patients
description: Patients tested negative for the hepatitis c virus antibodies by BIOLINE HCV kits.
intervention type: Diagnostic Test
intervention name: BIOLINE HCV kits
description: We used BIOLINE HCV kits to detect the presence of HCV antibodies in stick blood samples of all recruited patients.
arm group label: HCV negative patients
arm group label: HCV positive patients
other name: diagnosis of viral hepatitis C
intervention type: Diagnostic Test
intervention name: ACCU-CHEK kits
description: For all patients, we measured random blood sugar levels by stick blood samples using ACCU-CHEK kits.
arm group label: HCV negative patients
arm group label: HCV positive patients
other name: measurement of blood sugar level
intervention type: Diagnostic Test
intervention name: ErKameter 3000 mercury manometer
description: For all patients, we measured systolic blood pressure using ErKameter 3000 mercury manometer.
arm group label: HCV negative patients
arm group label: HCV positive patients
other name: blood pressure measurement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mina Wageh Mohareb
investigator title: Principal Investigator
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
sharing ipd: No
ipd description: No individual data will be shared with other researchers.