UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022053 |
|---|---|
| Receipt number | R000025389 |
| Scientific Title | An interventional study for activation of human brown adipose tissue |
| Date of disclosure of the study information | 2016/04/25 |
| Last modified on | 2020/05/18 13:58:13 |
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Basic information
Public title
An interventional study for activation of human brown adipose tissue
Acronym
An interventional study for activation of human brown adipose tissue
Scientific Title
An interventional study for activation of human brown adipose tissue
Scientific Title:Acronym
An interventional study for activation of human brown adipose tissue
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the activation of human brown adipose tissue after the performance of yoga exercises.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A standardized uptake value of FDG in PET scan before and after the performance of yoga exercises.
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Performance of yoga exercises.
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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Persons who have more than five years-experience of yoga.
2) Persons who is experienced in breathing of yoga for more than 30 minutes.
3) Persons aged from 25 to 65 years old.
4) Persons who consented to participate in the study.
Key exclusion criteria
1) Persons with any of follows; type 2 diabetes, thyroid diseases, malignancy, inflammative disorder, or collagen diseases.
2) Pregnant women.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Tobe |
Organization
University of Toyama
Division name
First Department of Internal Medicine
Zip code
Address
2630 sugitani, toyama city
TEL
076-434-7287
tobe@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiho Fujisaka |
Organization
University of Toyama
Division name
First Department of Internal Medicine
Zip code
Address
2630 sugitani, toyama city
TEL
076-434-7287
Homepage URL
shihof@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 04 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 25 | Day |
Last modified on
| 2020 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025389
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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