## Protocol Section
### Identification Module
**NCT ID:** NCT03839979

**Brief Title:** HCV Viral Hepatitis, Blood Sugar Level and Systolic Blood Pressure in Egypt

**Official Title:** Association Between HCV Viral Hepatitis, Blood Sugar Level and Systolic Blood Pressure in the Egyptian Population

#### Organization Study ID Info
**ID:** One million healthy citizen 18
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2019-01-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-03-18

**Type:** ACTUAL

**Last Update Submit Date:** 2021-03-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2018-10-01

**Type:** ACTUAL

**Status Verified Date:** 2021-03

#### Study First Post Date
**Date:** 2019-02-15
**Type:** ACTUAL
**Study First Submit Date:** 2019-02-09
**Study First Submit QC Date:** 2019-02-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Mina Wageh Mohareb

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**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???

### Conditions Module

**Conditions:**

- Hepatitis C, Acute

- Diabetes

- Hypertension

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 71975

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Diagnostic Test: BIOLINE HCV kits

- Diagnostic Test: ACCU-CHEK kits

- Diagnostic Test: ErKameter 3000 mercury manometer

**Label:** HCV positive patients

#### Arm Group 2

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

**Intervention Names:**

- Diagnostic Test: BIOLINE HCV kits

- Diagnostic Test: ACCU-CHEK kits

- Diagnostic Test: ErKameter 3000 mercury manometer

**Label:** HCV negative patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HCV negative patients

- HCV positive patients

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

**Name:** BIOLINE HCV kits

**Other Names:**

- diagnosis of viral hepatitis C

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- HCV negative patients

- HCV positive patients

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

**Name:** ACCU-CHEK kits

**Other Names:**

- measurement of blood sugar level

**Type:** DIAGNOSTIC_TEST

#### Intervention 3

**Arm Group Labels:**

- HCV negative patients

- HCV positive patients

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

**Name:** ErKameter 3000 mercury manometer

**Other Names:**

- blood pressure measurement

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Detection of patients who are HCV positive or negative

**Measure:** HCV diagnosis

**Time Frame:** 20 minutes

**Description:** Detection of the percentage of patients with high blood sugar level in HCV positive or negative patients

**Measure:** Measurement of blood sugar level in mg/dl

**Time Frame:** 1 minute

**Description:** Detection of the percentage of patients with high systolic blood pressure in HCV positive or negative patients

**Measure:** Measurement of systolic blood pressure in mmHg

**Time Frame:** 1 minute

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria

* Egyptian citizens from 18 years to 80 years.

Exclusion Criteria:

* Patients younger than 18 years or older than 80 years

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Egyptian patients aged 18-80 years.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Asyut

**Country:** Egypt

**Facility:** Egyptian Ministry of Health

**Zip:** 01234567

### IPD Sharing Statement Module

**Description:** No individual data will be shared with other researchers.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018178

- Term: Flaviviridae Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M27583

- Name: Systolic Murmurs

- Relevance: LOW

- As Found: Unknown

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9611

- Name: Hepatitis C

- Relevance: HIGH

- As Found: Hepatitis C

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20324

- Name: Flaviviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006526

- Term: Hepatitis C

- ID: D000006505

- Term: Hepatitis

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M20971

- Name: Hepatitis C Antibodies

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
