UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046639 |
|---|---|
| Receipt number | R000053204 |
| Scientific Title | Effect of acute social jetlag on risk factors of lifestyle-related diseases |
| Date of disclosure of the study information | 2022/01/17 |
| Last modified on | 2024/03/18 10:21:37 |
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Basic information
Public title
Effect of acute social jetlag on risk factors of lifestyle-related diseases
Acronym
Acute social jetlag and risk factors of lifestyle-related diseases
Scientific Title
Effect of acute social jetlag on risk factors of lifestyle-related diseases
Scientific Title:Acronym
Acute social jetlag and risk factors of lifestyle-related diseases
Region
| Japan |
Condition
Condition
Hypertension
Dyslipidemia
Type 2 diabetes
Metabolic syndrome
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of acute social jet lag on risk factors of lifestyle-related diseases in young men
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors of lifestyle-related diseases (fasting glucose, glucose levels after oral glucose tolerance test, 24 hours continuous glucose levels, insulin, HOMA-IR, morning and evening blood pressure, arterial stiffness, triglyceride, LDL cholesterol, HDL cholesterol)
Key secondary outcomes
Arterial baroreceptor sensitivity
Liver function markers (AST, ALT, gamma GTP)
Kidney function markers (urea nitrogen, creatinine)
Uric acid
Inflammatory markers (CRP, TNF-alpha, IL-6, MPO, calprotectin)
Sleep quality
Hepatokine (FGF-21, RBP4)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
From Friday to Sunday, participants go to bed and get up 2-3 hours later than usual (weekday wake up time and bedtime).
Interventions/Control_2
From Friday to Sunday, participants go to bed and get up at the same hour as the weekday.
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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy young men who go to bed and get up at the same hour from Monday to Friday (day-to-day variability less than 2 hours).
Key exclusion criteria
Shift worker
Cigarette smoker
Recipient of a drug
Participants who could not go to bed and get up at the same hour from Monday to Friday during the experiment
Participants who cannot follow researcher's instructions
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kumpei |
| Middle name | |
| Last name | Tanisawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
3591192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
0429476745
tanisawa@waseda.jp
Public contact
Name of contact person
| 1st name | Kumpei |
| Middle name | |
| Last name | Tanisawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
3591192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
0429476745
Homepage URL
tanisawa@waseda.jp
Sponsor or person
Institute
Faculty of Sport Sciences, Waseda University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
1-104 Totsukamachi, Shinjuku-ku, Tokyo
Tel
0352721639
rinri@list.waseda.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
| 2022 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
SJL (average mid-sleep time on weekends - average mid-sleep time on weekdays) occurred only in the SJL trial (SJL: 181 min vs. CON: 8 min). Carotid-femoral pulse wave velocity (cfPWV) and morning blood pressure surge on Monday in the SJL trial were significantly higher than those on Friday in the SJL trial, and those on Monday in the CON trial.
Results date posted
| 2023 | Year | 07 | Month | 17 | Day |
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
Main results already published
Date of protocol fixation
| 2021 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053204
