UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029276 |
|---|---|
| Receipt number | R000033444 |
| Scientific Title | Activity of brown adipose tissue and characteristics of physical function in humans |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2018/03/29 21:40:58 |
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Basic information
Public title
Activity of brown adipose tissue and characteristics of physical function in humans
Acronym
Activity of brown adipose tissue and characteristics of physical function in humans
Scientific Title
Activity of brown adipose tissue and characteristics of physical function in humans
Scientific Title:Acronym
Activity of brown adipose tissue and characteristics of physical function in humans
Region
| Japan |
Condition
Condition
obesity or type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesized that the hepatokine selenoprotein P regulates the heat production in brown adipocytes. In fact, we found that hypothermia-resistance in selenoprotein P knockout mice and impairment in noradrenaline-induced heat production in primary brown adipocytes treated with selenoprotein P. In the current study, we measure blood levels of selenoprotein P in human subjects whose brown adipose tissue activity was measured by FDG-PET.
Basic objectives2
Others
Basic objectives -Others
Many researchers pay attention to decreased brown adipose tissue activity in people with obesity or type 2 diabetes. However, its mechanism is not fully understood.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between blood concentrations of hepatokine selenoprotein P and activity of brown adipose tissue measured by PET.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
Cases who are judged as inadequate for the subjects in the current study by the corresponding doctors of the current study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Misu |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Endocrinology and Metabolism
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa,Japan
TEL
+81-76-265-2712
hmisu@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Misu |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Endocrinology and Metabolism
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa,Japan
TEL
+81-76-265-2712
Homepage URL
hmisu@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Sciences
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
Address
Tel
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
| 2017 | Year | 12 | 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
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
| 2017 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We compare selenoprotein P concentrations with brown adipose activity in one group without intervention.
Management information
Registered date
| 2017 | Year | 09 | Month | 25 | Day |
Last modified on
| 2018 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033444
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
