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Comparison of life style and disease patterns between Catholic priests and the public using health screening data

Status Approved

  • First Submitted Date

    2021/03/24

  • Registered Date

    2021/04/05

  • Last Updated Date

    2021/03/24

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006054
    Unique Protocol ID XC20RIDI0058
    Public/Brief Title Comparison of life style and disease patterns between Catholic priests and the public
    Scientific Title Comparison of life style and disease patterns between Catholic priests and the public using health screening data
    Acronym Carnus (cardiovascular risk of korean nun study)
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number XC20RIDI0058
    Approval Date 2020-05-18
    Institutional Review Board Name he Catholic University of Korea Catholic Medical Center Institutional Review Board
    Institutional Review Board Address 222, Banpo-daero, Seocho-gu, Seoul
    Institutional Review Board Telephone 02-2258-8203
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Sun Myeong Ock
    Title Professor
    Telephone +82-2-3779-1078
    Affiliation The Catholic University of Korea, Yeouido St. Mary's Hospital
    Address 10, 63-ro, Yeongdeungpo-gu, Seoul, Republic of Korea
    Contact Person for Public Queries
    Name Youngmi Eun
    Title Clinical Assistant
    Telephone +82-2-3779-1024
    Affiliation The Catholic University of Korea
    Address 10, 63-ro, Yeongdeungpo-gu, Seoul, Republic of Korea
    Contact Person for Updating Information
    Name Youngmi Eun
    Title Clinical Assistant
    Telephone +82-2-3779-1024
    Affiliation The Catholic University of Korea
    Address 10, 63-ro, Yeongdeungpo-gu, Seoul, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 5
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2020-06-18 Actual
    Target Number of Participant 14094
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study The Catholic University of Korea, Seoul St. Mary's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-06-18 ,
    Recruitment Status by Participating Study Site 2
    Name of Study The Catholic University of Korea, Yeouido St. Mary's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-06-18 ,
    Recruitment Status by Participating Study Site 3
    Name of Study The Catholic University of Korea, Uijeongbu St. Mary’s Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-06-22 ,
    Recruitment Status by Participating Study Site 4
    Name of Study The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-06-18 ,
    Recruitment Status by Participating Study Site 5
    Name of Study The Catholic University of Korea, St. Vincent's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-06-22 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name The Catholic University of Korea
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name The Catholic University of Korea
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    To maintain and promote healthy conditions, it is necessary to practice and control the lifestyle. However, there is not much research on how religion-related lifestyles affect personal health. In some previous studies, it has been reported that the incidences of diseases (cardiovascular disease, cancer, and geriatric disease) are different due to differences in lifestyle habits such as dietary intake, abstinence, sleeping habits, smoking rate, and alcohol according to religious life. In particular, the living environment of Catholic priests is unique and different from those of the general population; such as many restrictions, discipline, stress, and difficult-to-control eating habits. These factors can affect their health. Therefore, this study aims to observe the effect of religious ascetic life on health by comparing the health status of Catholic priests and ordinary people.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-control
    Time Perspective Cross-sectional  
    Target Number of Participant 14094
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Catholic priest

    Cohort/Group Description

    This study will observe the Catholic priests over 19 years of age who performed health check-ups at affiliated hospitals under the Catholic Central Medical Center from January 1, 2010, to December 31, 2019. To find out the differences between catholic priests and the general population in obesity and cardiovascular disease, mental health, and cancer marker, so we will compare physical examination, clinical tests, brain magnetic resonance imaging, and abdominal or cardiovascular CT tests.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    The Catholic priests over 19 years of age who performed health check-ups at affiliated hospitals under the Catholic Central Medical Center from January 1, 2010, to December 31, 2019.
    Sampling Method
    Non-probablity sampling: The Catholic priests who are over the age of 19 and performed health check-ups at affiliated hospitals under the Catholic Central Medical Center from January 1, 2010, to December 31, 2019, are all will be selected.
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E66.9)Obesity, unspecified 

    Obesity and cardiovascular disease.
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    The Catholic priests over 19 years of age who performed health check-ups at affiliated hospitals under the Catholic Central Medical Center from January 1, 2010, to December 31, 2019.
    Exclusion Criteria
    -The history of severe wasting diseases such as thyroid disease, liver disease, kidney disease, or malignant tumor within 3 months of the test. 
    -Severe infection, metabolic acidosis, acromegaly, and Cushing's syndrome. 
    -Incompetent of the medical records.
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    Prevalence obesity
    Timepoint
    After registration of the subject's medical record information
    Secondary Outcome(s) 1
    Outcome
    BMI, HOMA-IR, visceral fat, lipid profile, FBS, HbA1C, brain segmentation volume, HRV, PSA, and BMD
    Timepoint
    After registration of the subject's medical record information
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2022. 4
    Way of Sharing Available on Request
    (iron1600@catholic.ac.kr)
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