UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026395 |
|---|---|
| Receipt number | R000030274 |
| Scientific Title | Brown adipose tissue using a imaging new ultrasound technique: AINU study |
| Date of disclosure of the study information | 2017/03/07 |
| Last modified on | 2018/03/08 16:46:21 |
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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
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
nsakane@kyotolan.hosp.go.jp
Sponsor or person
Institute
Division of Preventive Medicine, Clinical Research Institute, Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030274
