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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Hypertension
Dyslipidemia Type 2 diabetes Metabolic syndrome |
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Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |