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
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
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 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
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
1. Source of Monetary/Material Support | |
---|---|
Organization Name | The Catholic University of Korea |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | The Catholic University of Korea |
Organization Type | University |
7. Study Summary
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 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
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)
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
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
---|---|
Time of Sharing | 2022. 4 |
Way of Sharing | Available on Request
(iron1600@catholic.ac.kr) |
TOP
BOTTOM
화면 최하단으로 이동