UMIN-CTR Clinical Trial

Basic information
Public title	Measurement of Brown Adipose Tissue Amount of Diabetic Patients by using Near-infrared Time Resolved Spectroscopy
Acronym	Measurement of Brown Adipose Tissue Amount of Diabetic Patients by using Near-infrared Time Resolved Spectroscopy
Scientific Title	Measurement of Brown Adipose Tissue Amount of Diabetic Patients by using Near-infrared Time Resolved Spectroscopy
Scientific Title:Acronym	Measurement of Brown Adipose Tissue Amount of Diabetic Patients by using Near-infrared Time Resolved Spectroscopy
Region	Japan

Condition
Condition	Type 2 Diabetes, Obesity
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to measure brown adipose tissue mass of type 2 diabetes patients by using near-infrared time-resolved spectroscopy (NIR(TRS)) and to examine its relationship to adiposity, age, environmental factors such as temerature as well as clinical factors such as diabetic controls and polymorphisms of genes, which were shown to be related to brown adipose mass measured by FDG-PET. Additional aim is to explore clinical factors that are associated with the brown adipose tissue mass measured by NIR(TRS).
Basic objectives2	Others
Basic objectives -Others	To examine the effectiveness of NIR(TRS) for the measurement of brown adipose tissue mass in type 2 diabetes patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The Primary endpoint of the study is to measure brown adipose tissue mass of type 2 diabetes patients by using near-infrared time-resolved spectroscopy (NIR(TRS)) and to examine its relationship to adiposity including body mass index and percent body fat.
Key secondary outcomes	The secondary outcome of the study is to examine brown adipose tissue mass of type 2 diabetes patients by using NIR(TRS) and examine its relationship between age and environmental factors such as temperature as well as clinical factors such as diabetic controls and polymorphisms of genes, which were shown to be related to brown adipose mass measured by FDG-PET.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	The investigator will measure intercapillary and intravenula hemoglobin concentration at supraclavicular, deltoid and abdominal area by using near-infrared time-resolved spectroscopy (NIR-TRS).
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	Diabetic patients who are more than 20 years old, given through explanation and understand the purpose of the study and who agree to participate in the study with a written informed consent.
Key exclusion criteria	- Those who disagree to participate in the study - Those who have serious diseases other than type 2 diabetes.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hironori Middle name Last name Waki
Organization	The University of Tokyo Hospital
Division name	Department of Diabetes and Metabolic Diseases
Zip code	113-8655
Address	7-3-1 Hongo Bunkyo Tokyo, Japan
TEL	+81-3-3815-5411-30254
Email	wakih-int@h.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Hironori Middle name Last name Waki
Organization	The University of Tokyo Hospital
Division name	Department of Diabetes and Metabolic Diseases
Zip code	113-8655
Address	7-3-1 Hongo Bunkyo Tokyo, Japan
TEL	+81-3-3815-5411-30254
Homepage URL
Email	wakih-int@h.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Medical University, Department of Sports Medicine for Health Promotion
Name of secondary funder(s)	AMED

IRB Contact (For public release)
Organization	Office for Human Research Studies(OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address	Faculty of Medicine Bldg.2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel	+81-3-5841-0818
Email	ethics@m.u-tokyo.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2016-102
Org. issuing International ID_1	Tokyo Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	明治安田生命健康保険組合東京診療所

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 28 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	No longer recruiting
Date of protocol fixation	2017 Year 02 Month 09 Day
Date of IRB	2017 Year 01 Month 27 Day
Anticipated trial start date	2017 Year 02 Month 09 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 28 Day
Last modified on	2019 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029473