UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053934 |
|---|---|
| Receipt number | R000061552 |
| Scientific Title | Cross-sectional study on metabolic fate determination of brown adipose tissue and its impact on energy homeostasis |
| Date of disclosure of the study information | 2024/04/24 |
| Last modified on | 2024/04/24 15:26:46 |
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Basic information
Public title
Cross-sectional study on metabolic fate determination of brown adipose tissue and its impact on energy homeostasis
Acronym
Metabolic fate of brown fat and energy homeostasis
Scientific Title
Cross-sectional study on metabolic fate determination of brown adipose tissue and its impact on energy homeostasis
Scientific Title:Acronym
Metabolic fate of brown fat and energy homeostasis
Region
| Japan |
Condition
Condition
Healthy adult volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate mechanisms by which environmental stimuli determine metabolic fate of brown adipose tissue and risks of obesity-related disorders.
Basic objectives2
Others
Basic objectives -Others
Physiological significance
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Brown adipose tissue activity assessed by FDG-PET/CT and density by NIR-TRS
Key secondary outcomes
Body composition, waist circumference, abdominal fat area, blood parameters including hormones and metabolites, brown fat mass, energy expenditure, respiratory quotient, diet history and nutritional intake, heart rate, blood pressure, adiposity at early lifestages, and epigenetic information in a certain type of cells.
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
<FDG-PET/CT>
1. Healthy adult volunteers
2. Aged 18 and over
3. Male and female
4. Individuals who have given written consent to participate in the study
<NIR-TRS>
1. Healthy adult volunteers
2. Aged 18 and over
3. Male and female
4. Individuals who have given written consent to participate in the study
<Epigenome>
1. Volunteers who underwent FDG-PET/CT
2. Aged 18 and over
3. Male
4. Volunteers with high, moderate, and low brown fat activity.
5. Individuals who have given written consent to participate in the study
Key exclusion criteria
<FDG-PET/CT>
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 pregnant or breastfeeding
5. Individuals who are considered unsuitable for the study by investigators or medical doctor due to other reasons.
<NIR-TRS>
1. Individuals with 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 with BMI 30 kg/m^2 or more.
3. Individuals with visceral fat area over 100cm^2.
4. Individuals who are considered unsuitable for the study by investigators or medical doctor due to other reasons.
<Epigenome>
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 investigators due to other reasons.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoneshiro |
Organization
Tohoku University
Division name
Division of Molecular Physiology and Metabolism, Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
+81227178177
takeshi.yoneshiro.a8@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoneshiro |
Organization
Tohoku University
Division name
Division of Molecular Physiology and Metabolism, Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
+81227178177
Homepage URL
takeshi.yoneshiro.a8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
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
The University of Tokyo
Tenshi College
Tokyo Medical University
LSI Sapporo Clinic
Name of secondary funder(s)
Japan Science and Technology Agency
Japan Society for the Promotion of Science
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
+81227284105
ec@rinri.hosp.tohoku.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
東北大学（宮城県）
東京大学（東京都）
天使大学（北海道）
東京医科大学（東京都）
LSI札幌クリニック（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
UMIN000050690 is an associate study to this study.
Management information
Registered date
| 2024 | Year | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061552
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| Registered date | File name |
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| Registered date | File name |
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