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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046639
Receipt No. 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 2022/01/14

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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 Blood glucose (fasting, after oral glucose tolerance test, 24 hours continuous measurement)
Key secondary outcomes Morning and evening blood pressure
Arterial stiffness
Arterial baroreceptor sensitivity
Blood lipids (triglyceride, LDL cholesterol, HDL cholesterol)
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

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
Email 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
Email tanisawa@waseda.jp

Sponsor
Institute Faculty of Sport Sciences, Waseda University
Institute
Department

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
Email 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 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 Enrolling by invitation
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
2022 Year 01 Month 14 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053204

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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