UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026326 |
|---|---|
| Receipt number | 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 22:04:46 |
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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
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
wakih-int@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029473
