UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026015 |
|---|---|
| Receipt number | 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 | 2022/06/29 11:58:10 |
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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
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
w014ub@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
Results
Glucose tolerance was better at 8 am, which was explained by the higher 1h insulin secretion and increased skeletal muscle insulin sensitivity. Hepatic insulin sensitivity was better at 8 pm. The insulin secretion and hepatic insulin resistance index correlated significantly with Per2 mRNA expression. The change in the GIR correlated significantly with the change in NEFA, but not with clock gene expressions. The change in NEFA correlated significantly with E4bp4 mRNA expression and the change in cortisol.
Results date posted
| 2022 | Year | 06 | Month | 29 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Analysis is delayed
Date of the first journal publication of results
Baseline Characteristics
Study participants were required to be aged between 20 and 60 years at the time of screening, and to have no obvious diabetes or impaired glucose tolerance. They were not regularly engaged in shift work, nor taking any medicine regularly. We did not enroll women because of the possible changes in glucose tolerance due to the menstrual cycle.
Participant flow
We confirmed that all of the enrolled participants did not have diabetes according to glycated hemoglobin (HbA1c) and fasting
blood glucose values. Either OGTT or HE clamp was carried out twice on the same participant at 8 am and 8 pm in random order at an interval of 5 days to 2 weeks. A total of 14 participants were enrolled for the OGTT, and 10 for the HE clamp study between January 2017 and November 2019. All study participants fasted for 10-13 h before each examination.
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 06 | Day |
Last modified on
| 2022 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029904
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/02/09 | DBP臨床研究計画書 ver2.0.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
