UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051136 |
|---|---|
| Receipt number | R000058304 |
| Scientific Title | Association of cigarette smoking habits and total serum bilirubin on inflammation |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2024/01/22 12:17:11 |
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Basic information
Public title
Habitual cigarette smoking may be associated with a lower total serum bilirubin level leading to higher inflammation: A cross-sectional study
Acronym
Association of cigarette smoking habits and total serum bilirubin on inflammation
Scientific Title
Association of cigarette smoking habits and total serum bilirubin on inflammation
Scientific Title:Acronym
Association of cigarette smoking habits and total serum bilirubin on inflammation
Region
| Japan |
Condition
Condition
Participants receiving annual health check
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine total serum bilirubin (TSB) levels in smokers and the association between TSB and inflammatory markers using a cross-sectional study approach in health screening participants with no history of atherosclerotic cardiovascular disease (ASCVD).
Basic objectives2
Others
Basic objectives -Others
The secondary purpose is to investigate the relationship between unhealthy lifestyle habits related to cigarette smoking habits and TSB.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the relationship between cigarette smoking habits and TSB.
Key secondary outcomes
The secondary endpoint is the relationship between unhealthy lifestyle habits related to cigarette smoking habits and TSB.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
This cross-sectional study focused on the primary prevention of ASCVD, examining the relationship between fish consumption, lifestyle, TSB, and inflammation. Among 11,678 Japanese individuals over 20 years who underwent annual health checkups between April 2019 and March 2020 at the Health Planning Center of Nihon University Hospital.
Key exclusion criteria
unwillingness to provide informed consent for participation, positive history of ASCVD, C-reactive protein (CRP)levels more than 2.0 mg/dL, the presence of hepatitis B virus surface antigen, hepatitis C antibodies, hepatic cirrhosis, hepatocellular carcinoma, and metastatic liver cancer or no measurement of leukocyte and leucocyte subclass count, CRP levels, and TSB levels. We also excluded participants with TSB levels of more than 2.0 mg/dL to exclude constitutional jaundice as much as possible.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Shigemasa |
| Middle name | |
| Last name | Tani |
Organization
Nihon University Hospital
Division name
Health Planning Center
Zip code
101-8309
Address
1-6 Kandasurugadai, chiyodaku, Tokyo, Japan
TEL
0332931711
tani.shigemasa@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigemasa |
| Middle name | |
| Last name | Tani |
Organization
Nihon University Hospital
Division name
Health Planning Center
Zip code
101-8309
Address
Kandasurugadai 1-6, Chiyodaku
TEL
0332931711
Homepage URL
tani.shigemasa@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Shigemasa Tani
Funding Source
Organization
Nihon University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Hospital IRB
Address
1-6 Kandasurugadai, chiyodaku
Tel
0332931711
tani.shigemasa@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This cross-sectional study focused on the primary prevention of ASCVD, examining the relationship between fish consumption, lifestyle, TSB, and inflammation. Among 11,678 Japanese individuals over 18 years who underwent annual health checkups between April 2019 and March 2020 at the Health Planning Center of Nihon University Hospital,
Management information
Registered date
| 2023 | Year | 05 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058304
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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