UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026326
Receipt No. R000029473
Scientific Title Measurement of Brown Adipose Tissue Amount of Diabetic Patients by using Near-infrared Time Resolved Spectroscopy
Date of disclosure of the study information 2017/02/28
Last modified on 2019/09/01

* 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 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/ctr_e/ctr_view.cgi?recptno=R000029473

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.