UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006066 |
|---|---|
| Receipt number | R000007127 |
| Scientific Title | Patho-physiology of Human Brown Adipose Tissue |
| Date of disclosure of the study information | 2011/08/10 |
| Last modified on | 2023/02/07 07:47:31 |
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Basic information
Public title
Patho-physiology of Human Brown Adipose Tissue
Acronym
Patho-physiology of Human BAT
Scientific Title
Patho-physiology of Human Brown Adipose Tissue
Scientific Title:Acronym
Patho-physiology of Human BAT
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Body weight and adiposity are modulated by brown adipose tissue (BAT). Uncoupling protein 1 (UCP1) of the BAT is involved in peripheral thermogenesis and energy expenditure under the control of sympathetic nervous system.
Recently, it was revealed that the BAT plays an important role even in human energy metabolism in the studies of positron-emission tomography and computed tomography (PETCT). Because of the function of human BAT shows the massive glucose uptake ratio compared to skeletal muscles and white adipose tissue (WAT) in the PETCT studies, the evaluation of BAT glucose uptake ratio (such as SUVmax) will be a clear indicator of BAT activity.
Previous studies had managed the results of the SUVmax as an indicator of BAT function at the stimulated state such as cold exposure. However, little studies had marked the results of the SUVmax at a resting state with warm condition.
In this study, we will reevaluate the PETCT medical examination of healthy subjects using PETCT and plain CT in association with the anthropometry, blood biochemistry study, serological study, body fat distribution and glucose/lipid metabolism. We will reach the insight into the accurate manner of regulation relevant to many modulators in various condition of BAT in our research.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
SUVmax and HU of BAT, WAT and skeletal muscle, Visceral fat area, Subcutaneous fat area, VS ratio, hemogram, liver function, glucose metabolism, lipid metabolism, amino acid metabolism.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 3,000 healthy subjects who agreed with the study in a document.
Key exclusion criteria
1) The subjects taking psychotropic drugs.
2) The subjects taking anti-diabetic drugs.
3) The subjects taking endocrine-modulating drugs.
4) The subjects who had malignant neoplasm disease.
5) The subject who received only either PETCT study or blood biochemistry study.
6) The subject of over 200 mg/dl blood glucose.
7) The restless subject before study.
8) The subject suffering obvious illness.
9) The subject getting pregnant.
10) The subject who was counted as an inappropriate case by researchers.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Seiichi |
| Middle name | |
| Last name | Chiba |
Organization
Oita University, Faculty of Medicine
Division name
Anatomy
Zip code
8795593
Address
1-1, Idaigaoka, Hazama, Yufu, Oita, Japan
TEL
097-586-5623
schiba@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiichi |
| Middle name | |
| Last name | Chiba |
Organization
Oita University, Faculty of Medicine
Division name
Anatomy
Zip code
8795593
Address
1-1, Idaigaoka, Hazama, Yufu, Oita, Japan
TEL
097-586-5623
Homepage URL
schiba@oita-u.ac.jp
Sponsor or person
Institute
Shonin Hospital, Shoninkai Medical Corporation.
Institute
Department
Personal name
Funding Source
Organization
Oita University, Faculty of Medicine
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
Oita University, Faculty of Medicine, Anatomy
Address
1-1, Idaigaoka, Hazama, Yufu, Oita, Japan
Tel
0975865623
schiba@oita-u.ac.jp
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
| 2011 | Year | 08 | Month | 10 | 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
100
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Now writing.
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Case control study
Management information
Registered date
| 2011 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007127
| 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 |
