UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056937 |
|---|---|
| Receipt number | R000065069 |
| Scientific Title | Establishing Reference Values for Blood Biomarkers to Assess Chronological Aging of the Human Circadian Clock and Investigation of Disease-Dependent Variations |
| Date of disclosure of the study information | 2025/02/05 |
| Last modified on | 2025/02/05 03:36:24 |
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Basic information
Public title
Study on Biological Clock Age
Acronym
Study on Biological Clock Age
Scientific Title
Establishing Reference Values for Blood Biomarkers to Assess Chronological Aging of the Human Circadian Clock and Investigation of Disease-Dependent Variations
Scientific Title:Acronym
Establishing Reference Values for Blood Biomarkers to Assess Chronological Aging of the Human Circadian Clock and Investigation of Disease-Dependent Variations
Region
| Japan |
Condition
Condition
healthy adults, diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to first establish an algorithm for estimating circadian rhythmicity from a limited number of samples using previously obtained gene profile data from young and elderly individuals. Subsequently, the study will attempt to establish reference values for age-dependent rhythmicity by collecting a small number of blood samples from healthy adults across multiple age groups. Additionally, rhythmicity assessments will be conducted in diabetic patients, a population strongly suspected to have impaired circadian function, to investigate the presence of disease-specific effects on circadian rhythms.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A set of molecules whose rhythms become abnormal with aging
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Males aged between 20 and 79 years
Diabetic patients aged between 20 and 79 years
Key exclusion criteria
1) Individuals with difficulty in blood collection due to alcohol allergy, vasovagal reflex, or other related conditions.
2) Individuals with sleep issues that deviate from the normal range, as determined by sleep questionnaires, sleep diaries, or actigraphy records.
3) Individuals with pre-existing conditions (such as cardiovascular, hepatic, endocrine, neurological, or psychiatric disorders) that may affect study results, those currently taking relevant medications, or those with a history of such conditions.
4) Individuals diagnosed with alcohol dependence or exhibiting excessive alcohol consumption habits.
5) Individuals who have engaged in shift work or traveled across time zones within six months prior to testing.
6) Individuals who have donated 200 mL of whole blood within four weeks or 400 mL of whole blood within 12 weeks prior to participation.
7) Any other individuals deemed inappropriate for participation by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kitamura |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders
Zip code
1870001
Address
4-1-1, Ogawa-Higashi, Kodaira Tokyo
TEL
042-346-2014
s-kita@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Kitamura |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders
Zip code
1870001
Address
4-1-1, Ogawa-Higashi, Kodaira Tokyo
TEL
042-346-2014
Homepage URL
s-kita@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
National Center of Neurology and Psychiatry Ethical Committee
Address
4-1-1, Ogawa-Higashi, Kodaira Tokyo
Tel
042-341-2711
ml_rinrijimu@ncnp.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
| 2025 | Year | 02 | Month | 05 | 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
| 2024 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study 1: Estimation of Rhythmicity Using a Limited Number of Samples
An algorithm will be developed to estimate circadian rhythmicity using one or two time points from previously obtained gene profile data. This dataset includes up to 13 time points of gene expression profiles collected from seven young and seven elderly individuals under both simulated daily life conditions and constant environmental conditions.
Study 2: Establishment of Reference Values Across Age Groups
Thirty healthy adult males will participate in a study conducted at National Center of Neurology and Psychiatry. Blood samples will be collected at two optimized time points, spaced several hours apart, as determined during algorithm development.
Prior to sampling, participants will record their sleep habits at home for 14 days using sleep diaries and actigraphy. Additionally, they will complete questionnaires related to sleep and circadian rhythms (MEQ, MCTQ, PSQI).
On the day of sampling, participants will visit the laboratory at the National Center of Neurology and Psychiatry, where two blood samples (5.5 mL each) will be drawn at the optimized time intervals. After the second blood draw, participants will be discharged. During the waiting period between blood draws, participants will be allowed to engage in free activities while remaining seated in the sampling area. If required due to the sampling interval, meals and water will be provided.
Study 3: Evaluation in Diabetic Patients
Diabetic inpatients at Kawaguchi Municipal Medical Center will undergo blood sampling at two optimized time points, spaced several hours apart, as determined during algorithm development. Since the study targets hospitalized patients, sleep and circadian rhythm assessments using home-based records will not be conducted.
Management information
Registered date
| 2025 | Year | 02 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065069
