UMIN-CTR Clinical Trial

Basic information
Public title	Brown adipose tissue using a imaging new ultrasound technique: AINU study
Acronym	AINU study
Scientific Title	Brown adipose tissue using a imaging new ultrasound technique: AINU study
Scientific Title:Acronym	AINU study
Region	Japan

Condition
Condition	Healthy Volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To visualige human brown adipose tissue using a ultrasound technique
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visualiging of human brown adipose tissue
Key secondary outcomes	brown adipose tissue activity, blood flow in brown adipose tissue, thermography, vascular image, body fat, Skin temperature, blood pressure, blood glucose, insulin, triglyceride, non-esterified fatty acid, thyroid stimulating hormone, T3, T4, cortisol, leptin, ghrelin, adiponectine etc

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	2 hour cold exposure using a standardized method.
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	1) Age>=18 2) Subjects who received FDG-PET/CT scan 3) Be able to provide written informed consent
Key exclusion criteria	1) Subjects who are judge a as unsuitable for the study by the investigator or medical doctor
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki Sakane
Organization	Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name	Division of Preventive Medicine
Zip code
Address	1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
TEL	+81-75-641-9161
Email	nsakane@kyotolan.hosp.go.jp

Public contact
Name of contact person	1st name Middle name Last name Naoki Sakane
Organization	Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name	Division of Preventive Medicine
Zip code
Address	1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
TEL	+81-75-641-9161
Homepage URL
Email	nsakane@kyotolan.hosp.go.jp

Sponsor
Institute	Division of Preventive Medicine, Clinical Research Institute, Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Kyoto Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Jyoto Orthpaedic Clinic Hokkaido University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 03 Month 07 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	Enrolling by invitation
Date of protocol fixation	2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 03 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 04 Day
Last modified on	2018 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030274

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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