UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043835 |
|---|---|
| Receipt number | R000049471 |
| Scientific Title | Study of monitoring on circadian rhythms of eating behavior and housing environment |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2023/04/09 16:46:11 |
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Basic information
Public title
Study of monitoring on circadian rhythms of eating behavior and housing environment
Acronym
Study on circadian rhythms of life-style
Scientific Title
Study of monitoring on circadian rhythms of eating behavior and housing environment
Scientific Title:Acronym
Study on circadian rhythms of life-style
Region
| Japan |
Condition
Condition
Diabetes, Dyslipidemia, Hypertension, Obesity
Classification by specialty
| Endocrinology and Metabolism | Nephrology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The conceptual framework of spatiotemporal adaptation to environment by circadian rhythms is extended to this study in humans by leveraging smart sensing and mobile apps. Since these novel technologies are potentially able to provide digital biomarkers reflective of behavioral and environmental daily rhythms in human that used to be inaccessible, this proposed study is likely to facilitate life-style modification by digital therapeutics, and intended to provide preventive measures by temporally restricted eating, fasting, and exercise. Monitoring and integrative analysis of eating behaviors, activities, and housing environments between office visits allow us to consider individual propensity thereby contributing to personalized and concrete prescription of appropriately timed diets and exercise.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of daily rhythmicity among the following measurements is explored as primary outcomes. Intrinsic factors such as salivary cortisol, melatonin, and microbiota in the oral cavity, along with heart rate, activity (exercise, walking, and calorie consumption), sleep (including but not limited to wakeup time and bedtime), subcutaneous glucose levels, in combination with diurnal variation of external factors such as eating behavior and housing environments (temperature, humidity, illumination, air pressure, noise, carbon dioxide concentration, air quality, ultraviolet levels, discomfort index, heat stroke risks, opening motions of refrigerators, and electricity usage) are evaluated.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Outpatients in the Department of Endocrinology, Metabolism, and Nephrology, Keio University Hospital.
1. Being at least 20 years of age and less than 80 years old when the consent is signed.
2. Patients deemed competent by doctors to execute this study such as handling a smartphone, installing fitness tracker, flush glucose monitoring, and environmental sensors.
3. Patients who sign a consent form based on his or her sufficient understanding and voluntary decision following adequate information on this study.
Key exclusion criteria
1. Patients on oral or intravenous adrenocorticosteroids, or melatonin receptor agonists.
2. Chronic kidney disease of estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2.
3. Patients using implanted medical devices such as cardiac pacemakers.
4. Patients with pregnancy or possible pregnancy.
5. Patients with poorly controlled psychiatric disorders
6. Patients unable to sign a consent form, to understand the outline and purpose of the study, or to need legally authorized representative.
7. Patients deemed unsuitable for the study by doctors
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Itoh |
Organization
Keio University School of Medicine
Division name
Department of Endocrinology, Metabolism, and Nephrology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3796
hiito@keio.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Kinouchi |
Organization
Keio University School of Medicine
Division name
Department of Endocrinology, Metabolism, and Nephrology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3796
Homepage URL
ken-k@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Endocrinology, Metabolism, and Nephrology, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
RIKEN Center for Integrative Medical Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2021 | Year | 06 | Month | 01 | 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
25
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 24 | 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
Prospective research
Management information
Registered date
| 2021 | Year | 04 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049471
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