UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031255 |
|---|---|
| Receipt number | R000035683 |
| Scientific Title | Relationship between brown adipose tissue activity and physiological functions in humans |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2025/02/17 10:04:08 |
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Basic information
Public title
Relationship between brown adipose tissue activity and physiological functions in humans
Acronym
Human brown adipose tissue and physiological functions
Scientific Title
Relationship between brown adipose tissue activity and physiological functions in humans
Scientific Title:Acronym
Human brown adipose tissue and physiological functions
Region
| Japan |
Condition
Condition
Healthy adult volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To analyze the relationship between brown adipose tissue activity and various physiological parameters including adiposity, metabolic syndrome-related parameters and SNP of target genes.
Basic objectives2
Others
Basic objectives -Others
Identification of physiological factors having a significant impact on brown adipose tissue activity
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Brown adipose tissue activity
Metabolic syndrome-related parameters
Adiposity
Key secondary outcomes
Body composition, waist circumference, abdominal fat area, blood parameters including hormones and metabolites, brown fat mass, energy expenditure, respiratory quotient, diet history and nutritional intake, heart rate, blood pressure, menstrual cycle, and Single nucleotide polymorphism of target genes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Healthy male and female volunteers
2)Aged 18 years <=
3)Be able to provide written informed consent
Key exclusion criteria
with a serious disease
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Mami |
| Middle name | |
| Last name | Matsushita |
Organization
Tenshi College
Division name
Department of Nutrition
Zip code
0650013
Address
Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL
011-741-1051
matsushita@tenshi.ac.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Matsushita |
Organization
Tenshi College
Division name
Department of Nutrition
Zip code
0650013
Address
Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL
011-741-1051
Homepage URL
matsushita@tenshi.ac.jp
Sponsor or person
Institute
Tenshi College, Department of Nutrition
Institute
Department
Personal name
Funding Source
Organization
Grants-In-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of Japan.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tenshi College
Address
Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
Tel
011-741-1051
horii@tenshi.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
天使大学（北海道） / Tenshi College (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 01 | 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
Brown adipose tissue activity is assessed by FDG-PET/CT for recruited subjects, and its relation to morphological and metabolic syndrome-related parameters including BMI, body fatness, blood pressure, blood glucose, blood triglyceride and blood cholesterol will be analyzed.
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For recruited subjects, their daily life-style and brown fat-related gene polymorphism are examined, and the relation to brown adipose tissue activity will be analyzed.
Management information
Registered date
| 2018 | Year | 02 | Month | 12 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035683
