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

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 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

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

Value
https://center6.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