UMIN-CTR Clinical Trial

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

Contact us.