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 2020/02/14 09:41:42

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Healthy male and female volunteers
2)Aged 20 years <=
3)Be able to provide written informed consent

Key exclusion criteria

with a serious disease

Target sample size

100


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

Email

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


Email

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

Email

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

2020 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035683


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name