UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050690 |
|---|---|
| Receipt number | R000057751 |
| Scientific Title | Elucidation of mechanisms of determination of brown adipocyte cell fate by lifestyle environment |
| Date of disclosure of the study information | 2023/03/27 |
| Last modified on | 2024/04/25 17:19:17 |
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Basic information
Public title
Elucidation of mechanisms of determination of brown adipocyte cell fate by lifestyle environment
Acronym
Fate determination of brown fat
Scientific Title
Elucidation of mechanisms of determination of brown adipocyte cell fate by lifestyle environment
Scientific Title:Acronym
Fate determination of brown fat
Region
| Japan |
Condition
Condition
Healthy adult volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To verify effects of lifestyle environment such as outdoor temperature at early life stage on brown adipose tissue activity and adiposity in human adults
Basic objectives2
Others
Basic objectives -Others
Physiological significance
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cohort 1:Brown adipose tissue activity by FDG-PET/CT
Cohort 2:Brown adipose tissue density by NIR-TRS
Key secondary outcomes
Body Mass Index (BMI), visceral fat area, blood pressure, total energy expenditure, blood glucose level, blood lipid concentration and concentration of other metabolites.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Cohort1>
1. Healthy adult volunteers
2. Aged 18 and over
3. Individuals who have given written consent to participate in the study
<Cohort2>
1. Healthy adult volunteers
2. Aged 18 and over
3. Individuals who have given written consent to participate in the study
<Epigenome analysis>
1. Volunteers whose brown adipose tissue has been evaluated by FDG-PET/CT examination
2. Aged 18 and over
3. Male
4. Individuals who have given written consent to participate in the study
Key exclusion criteria
<Cohort1>
1. Individuals with dysfunction of liver, renal, cardiovascular, respiratory, endocrine and nervous systems, or with metabolic disorders, diabetes, consciousness disorders or other disease.
2. Individuals who regularly take medications for diabetes, hyperlipidemia or hypertension.
3. Individuals who smoke over 21 cigarettes a day or consume alcohol more than 30g a day on average.
4. Individuals who are considered unsuitable for the study by investigators or medical doctor due to other reasons.
<Cohort2>
1. Individuals who have the following conditions: glucose intolerance, hyperlipidemia, hypertension, hyperuricemia/gout, coronary artery disease, cerebral infarction, non-alcoholic fatty liver disease, menstrual disorder, sleep apnea syndrome, motor system disease, obesity-related kidney disease or cardiovascular risk.
2. Individuals whose BMI is 30 kg/m2 or more.
3. Individuals with visceral fat area over 100cm2.
<Epigenome analysis>
1. Individuals with dysfunction of liver, renal, cardiovascular, respiratory, endocrine and nervous systems, or with metabolic disorders, diabetes, consciousness disorders or other disease.
2. Individuals who regularly take medications for diabetes, hyperlipidemia or hypertension.
3. Individuals who smoke over 21 cigarettes a day or consume alcohol more than 30g a day on average.
4. Female.
5. Individuals who are considered unsuitable for the study by the principal investigator due to other reasons.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoneshiro |
Organization
The University of Tokyo
Division name
Division of Metabolic Medicine, Research Center for Advanced Science and Technology
Zip code
153-8904
Address
Room 310 Building 4, 4-6-1 Komaba, Meguro-ku, Tokyo
TEL
+81354525472
yoneshiro.takeshi@lsbm.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoneshiro |
Organization
The University of Tokyo
Division name
Division of Metabolic Medicine, Research Center for Advanced Science and Technology
Zip code
153-8904
Address
Room 310, Building 4, 4-6-1 Komaba, Meguro-ku, Tokyo
TEL
+81354525472
Homepage URL
yoneshiro.takeshi@lsbm.org
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University
Hokkaido University
Tenshi College
Tokyo Medical University
Name of secondary funder(s)
Japan Science and Technology Agency
Japan Society for the Promotion of Science
IRB Contact (For public release)
Organization
The University of Tokyo
Address
7-3-1 Hongo,Bunkyo-ku,Tokyo
Tel
+81358411580
lifescience.adm@gs.mail.u-tokyo.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
東京大学（東京都）
天使大学（北海道）
東京医科大学（東京都）
東北大学（宮城県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 27 | 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
Not reported
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057751
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