UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Activity of brown adipose tissue and characteristics of physical function in humans
Title of the study (Brief title)	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	Hirofumi Misu
Organization	Kanazawa University Graduate School of Medical Sciences
Division name	Department of Endocrinology and Metabolism
Address	13-1 Takara-machi, Kanazawa, Ishikawa,Japan
TEL	+81-76-265-2712
Email	hmisu@m-kanazawa.jp

Public contact
Name of contact person	Hirofumi Misu
Organization	Kanazawa University Graduate School of Medical Sciences
Division name	Department of Endocrinology and Metabolism
Address	13-1 Takara-machi, Kanazawa, Ishikawa,Japan
TEL	+81-76-265-2712
Homepage URL
Email	hmisu@m-kanazawa.jp

Sponsor
Institute	Kanazawa University Graduate School of Medical Sciences
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 09 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033444