UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053207 |
|---|---|
| Receipt number | R000060724 |
| Scientific Title | The impact of aerobic exercise habits on total serum bilirubin levels and their implications as a mediator of anti-atherosclerosis mechanisms |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2024/01/22 12:18:02 |
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Basic information
Public title
The impact of aerobic exercise habits on total serum bilirubin levels and their implications as a mediator of anti-atherosclerosis mechanisms
Acronym
The impact of aerobic exercise habits on total serum bilirubin levels and their implications as a mediator of anti-atherosclerosis mechanisms
Scientific Title
The impact of aerobic exercise habits on total serum bilirubin levels and their implications as a mediator of anti-atherosclerosis mechanisms
Scientific Title:Acronym
The impact of aerobic exercise habits on total serum bilirubin levels and their implications as a mediator of anti-atherosclerosis mechanisms
Region
| Japan |
Condition
Condition
annual health-checked participants
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine the association between aerobic exercise habits, serum TSB, and inflammatory markers in annual health-checked participants without a history of ASCVD and to examine the role of TSB as a mediator in the association between aerobic exercise habits and inflammatory markers using causal median analysis.
Basic objectives2
Others
Basic objectives -Others
Comparisons of inflammatory markers between participants with aerobic exercise habits and without aerobic exercise habits
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparisons of participant characteristics, laboratory profiles, and lifestyle behaviors between participants with aerobic exercise habits and those without aerobic exercise habits
Key secondary outcomes
Comparison of total serum bilirubin levels between participants with aerobic exercise habits or without aerobic exercise habits
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Of 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,
Key exclusion criteria
We excluded 3,381 participants from the analysis according to the following criteria: unwillingness to provide informed consent for participation; positive history of ASCVD; leukocyte count more than 10000; C-reactive protein (CRP) level more than 3. 0 mg/dL; no record of frequency of fish consumption; presence of hepatitis B virus surface antigen, hepatitis C antibodies, liver cirrhosis, hepatocellular carcinoma, and metastatic liver cancer; or no measurement of white blood cell 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 (i.e., the cut-off was to diagnose Gilbert syndrome in the absence of liver dysfunction). In addition, because there are cases in which TSB is higher in fasting blood samples than in random blood samples, we set the cut-off for TSB concentrations higher than the reference value
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 of Nihon University Hospital
Zip code
1018309
Address
1-6 Kandasurugadai, chiyodaku, Tokyo, Japan
TEL
09080537841
tani.shigemasa@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigemasa |
| Middle name | |
| Last name | Tani |
Organization
Nihon University Hospital Health Planning Center
Division name
Nihon University Hospital Health Planning Center
Zip code
1018309
Address
Chiyodaku-kandasurugadai 1-6, Tokyo
TEL
09080537841
Homepage URL
tani.shigemasa@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital, Health Planning Center
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
Kandasurugadai1-6, Chiyodaku, Tokyo
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 | 12 | Month | 25 | 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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2003 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2023 | Year | 12 | 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=R000060724
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| Registered date | File name |
| Research case data | |
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