UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039617 |
|---|---|
| Receipt number | R000045183 |
| Scientific Title | Circadian clock evaluation using hair follicle cells |
| Date of disclosure of the study information | 2020/02/27 |
| Last modified on | 2021/03/07 21:30:30 |
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Basic information
Public title
Circadian clock evaluation using hair follicle cells
Acronym
Circadian clock evaluation using hair follicle cells
Scientific Title
Circadian clock evaluation using hair follicle cells
Scientific Title:Acronym
Circadian clock evaluation using hair follicle cells
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Many physiological phenomena are known to have diurnal variations, many of which are controlled by a circadian clock. The circadian clock is constructed by a group of clock genes, and the expression rhythm of these clock genes is the main body of the circadian clock. Therefore, a circadian clock can be diagnosed by evaluating the expression pattern of a clock gene. Circadian clock evaluation using hair follicles has already been introduced by other universities and research institutions, and its safety and other factors have been confirmed. Circadian clock dysfunction has been shown to be at risk for various diseases such as psychiatric disorders, sleep disorders, cardiovascular diseases, and diabetes, and also to be important in the pathology of intractable neurological diseases such as Parkinson's disease. Thus, circadian clock measurements may contribute to the prevention and treatment of many diseases caused by circadian rhythm disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Age, gender, wake-up time/ meal time/ bedtime, activity, sleep status, name of medicine, disease duration, Sleep questionnaire (ESS, RBD score, PDSS-2), hair follicle (clock gene expression levels (Period1, Period2, Period3, Cryptochrome1, Cryptochrome2, Bmal1, Npas2, Nr1d1, Nr1d2, DBP, DEC1, DEC2, etc.))
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
At the beginning of the observation period, patients who satisfy all of the following conditions are included.
1) The consent has been obtained from the participant himself / herself through the explanatory document and consent form
2) Age at the time of obtaining consent is 20 years or older and less than 85 years. Both men and women.
3) Parkinson's disease patients with H & Y I or higher.
Key exclusion criteria
1) Patients with drug addiction / alcoholism
2) Patients with severe physical symptoms other than Parkinson's disease (heart, liver, renal dysfunction, hematopoietic disorders, etc.)
3) Patients with severe mental symptoms (confusion, hallucinations, delusions, abnormal behavior, etc.) within 3 months before obtaining consent form
4) Other patients who are judged inappropriate to participate in the study by the attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takuyuki |
| Middle name | |
| Last name | Endo |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Department of Neurology
Zip code
5608552
Address
5-1-1, Toneyama, Toyonaka, Osaka
TEL
+81-6-6853-2001
endo.takuyuki.gr@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Takuyuki |
| Middle name | |
| Last name | Endo |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Department of Neurology
Zip code
5608552
Address
5-1-1, Toneyama, Toyonaka, Osaka
TEL
+81-6-6853-2001
Homepage URL
endo.takuyuki.gr@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Osaka Toneyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Osaka Toneyama Medical Center Clinical Research Review Committee
Address
5-1-1, Toneyama, Toyonaka, Osaka
Tel
+81-6-6853-2001
410-chiken@mail.hosp.go.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
| 2020 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-020-64645-6
Number of participants that the trial has enrolled
16
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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 06 | 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
1. The subjects are inpatients.
2. The subjects receive written explanation of the study from the attending physician and sign the consent form.
3. The subjects undergo sleep evaluation (ESS, RBD score, PDSS-2) using a questionnaire.
4. The subjects adjust their lifestyle habits one week before the test day and record their wake-up time, meal time and bedtime. Furthermore, an activity measuring device (portable activity meter) is worn.
5. On the test day, we collect about 5 hair follicles (from hair or beard) every 8 hours for 24 hours. The collection location is in the ward, where nurses collect.
6. We place the collected hair roots in an Eppendorf tube containing reagents for RNA purification, and store frozen.
7. Using cells attached to hair follicles, we measure expression levels of clock genes (Period1, Period2, Period3, Cryptochrome1, Cryptochrome2, Bmal1, Npas2, Nr1d1, Nr1d2, DBP, DEC1, DEC2, etc.).
8. We determine the circadian clock phase from these data by performing cosine curve fitting. We examine the correlation between the obtained clock gene expression rhythm phase results and the characteristics of the subjects (sleep status, age, gender, weight, basal body temperature, lifestyle, basic disease, medication, etc.).
Management information
Registered date
| 2020 | Year | 02 | Month | 27 | Day |
Last modified on
| 2021 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045183
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