UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050005 |
|---|---|
| Receipt number | R000056959 |
| Scientific Title | Establishment of a simple evaluation method for the human circadian clock activity |
| Date of disclosure of the study information | 2023/01/11 |
| Last modified on | 2024/07/31 13:29:11 |
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Basic information
Public title
Establishment of a simple evaluation method for the human circadian clock activity
Acronym
Establishment of a simple evaluation method for the human circadian clock activity
Scientific Title
Establishment of a simple evaluation method for the human circadian clock activity
Scientific Title:Acronym
Establishment of a simple evaluation method for the human circadian clock activity
Region
| Japan |
Condition
Condition
Pancreatic cancer, sleep disorders, diabetes, hypertension
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Irregular lifestyles, such as shift work, can modify the body clock system, resulting in increased health risks, such as insomnia, obesity, ischemic heart disease, diabetes, and mental illness. Therefore, measuring the biological clock system and evaluating its state can help predict the risk of these diseases and take appropriate preventive measures. Methods for measuring the biological clock system in humans include measuring the expression of clock genes in cultured cells prepared from isolated skin or hair follicle cells of individuals and measuring the amount of melatonin in the blood. However, these methods require the collection of skin, hair follicle, and blood samples, which is burdensome for the subject. Therefore, there is a need for a non-invasive and simple method. Based on the above, this study aims to develop a new method to measure circadian rhythms in a simple and noninvasive manner and obtain basic data to further clarify the relationship between diseases and the body clock.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Clock gene expression in saliva at 6:00, 12:00, 18:00 and 24:00
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Subjects are given a saliva RNA collection and storage device, and they use the device to collect their own saliva (approximately 2 ml) at 6:00, 12:00, 18:00, and 24:00.
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
1. Healthy adult Japanese male
2. Age at the time of consent: 20 to 29 years old
3. BMI between 19 and 25
4. Never smoked in the past.
Key exclusion criteria
1. Participated in another clinical trial or clinical study within 2 weeks of the study, or is currently participating in another clinical trial or clinical study
2. Received any drug, over-the-counter drug, or dietary supplement within 3 days of the study
3. Persons who are bleeding, have a predisposition or tendency to bleeding, or have a history of bleeding.
4. Persons with abnormal blood tests or other abnormalities in organ function in previous physical examinations.
5. Persons with any history of thyroid function.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Shimba |
Organization
Nikon University, School of Pharmacy
Division name
Laboratory of Health Science
Zip code
274-8555
Address
7-7-1 Narashinodai, Funabashi, Chiba
TEL
047-465-5838
shimba.shigeki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Shimba |
Organization
Nihon University, School of Pharmacy
Division name
Laboratory of Health Science
Zip code
274-8555
Address
7-7-1 Narashinodai, Funabashi, Chiba
TEL
047-465-5838
Homepage URL
shimba.shigeki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon University, School of Pharmacy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Pharmacy
Address
7-7-1 Narashinodai, Funabashi, Chiba
Tel
047-465-5838
shimba.shigeki@nihon-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
| 2023 | Year | 01 | Month | 11 | 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
| 2022 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056959
