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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026015
Receipt No. R000029904
Scientific Title The difference in glucose metabolism between morning and evening, and its association with the expression of clock genes.
Date of disclosure of the study information 2017/02/10
Last modified on 2019/08/13

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Basic information
Public title The difference in glucose metabolism between morning and evening, and its association with the expression of clock genes.
Acronym The difference in glucose metabolism between morning and evening, and its association with the expression of clock genes.
Scientific Title The difference in glucose metabolism between morning and evening, and its association with the expression of clock genes.
Scientific Title:Acronym The difference in glucose metabolism between morning and evening, and its association with the expression of clock genes.
Region
Japan

Condition
Condition healthy adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The difference in glucose metabolism between morning and evening, and its association with the expression of clock genes.
Basic objectives2 Others
Basic objectives -Others The difference in glucose metabolism between morning and evening
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference in glucose metabolism between morning and evening
Key secondary outcomes The difference in lipids, hormones and the RNA expression of clock gene in hair root between morning and evening

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Undergoing two 75 gram oral glucose tolerance tests or hyperinsulinemic euglycemic glucose cramps, one at 0800 h and a second at 2000 h on other day
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
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria health adults
Key exclusion criteria 1) subject with impaired glucose tolerance
2) on a chronic medication
3) shift worker
4) pregnant
5) they reject harvest their hair roots
Target sample size 22

Research contact person
Name of lead principal investigator
1st name Yasuharu
Middle name
Last name Ohta
Organization Yamaguchi University School of Medicine
Division name The Department of Diabetes Research
Zip code 755-8505
Address 1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL 0836-22-2251
Email yohta@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name RURIKO
Middle name
Last name FUJIMOTO
Organization Yamaguchi University Graduate School of medicine
Division name Devision of Endcrinology, Metabolism, Hematological Science Therapeutics
Zip code 755-8505
Address 1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL 0836-22-2251
Homepage URL
Email w014ub@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

Funding Source
Organization Yamaguchi University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor The Research Insitute for Time Studies at Ymaguchi University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yamaguchi University Graduate School of medicine
Address 1-1-1 Minami-kogushi, Ube, Yamaguchi
Tel 0836-22-2251
Email w014ub@yamaguchi-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
2017 Year 02 Month 10 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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 13 Day
Date of IRB
2016 Year 12 Month 13 Day
Anticipated trial start date
2017 Year 01 Month 30 Day
Last follow-up date
2021 Year 03 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
2017 Year 02 Month 06 Day
Last modified on
2019 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029904

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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