UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022833
Receipt number R000026249
Scientific Title Effects of non exercise activity thermogenesis(NEAT) on metabolic parameters in patients with type 2 diabetes
Date of disclosure of the study information 2016/07/01
Last modified on 2021/12/28 15:32:24

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Basic information

Public title

Effects of non exercise activity thermogenesis(NEAT) on metabolic parameters in patients with type 2 diabetes

Acronym

Effects of non exercise activity thermogenesis(NEAT) on type 2 diabetes

Scientific Title

Effects of non exercise activity thermogenesis(NEAT) on metabolic parameters in patients with type 2 diabetes

Scientific Title:Acronym

Effects of non exercise activity thermogenesis(NEAT) on type 2 diabetes

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of NEAT on physical activity level, energy expenditure, and metabolic parameters.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Physical activity level and daily energy expenditure measured by a triaxial accelerometer

Key secondary outcomes

Glycemic control, body composition, and indices of arterioscrelosis


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Instructions to increase NEAT in daily life.
For example, "stepping activity in a seated position"

Interventions/Control_2

Controls.

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

Adult patients who are diagnosed as having type 2 diabetes according to Japanese diagnostic criteria of type 2 diabetes.
Subjects do not engage in any sports like activities during study period.

Key exclusion criteria

Type 1 diabetes or anti-GAD-positive patients
Hyperglycemic emergency
Subjects with ADL impairment

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hidekatsu
Middle name
Last name Yanai

Organization

National Center for Global Health and Medicine Kohnodai Hospital

Division name

assistant director

Zip code

272-8516

Address

1-7-1, Kohnodai, Chiba, Japan

TEL

0473723501

Email

dyanai@hospk.ncgm.go.jp


Public contact

Name of contact person

1st name Hidetaka
Middle name
Last name Hamasaki

Organization

National Center for Global Health and Medicine Kohnodai Hospital

Division name

Department of Internal Medicine

Zip code

272-8516

Address

1-7-1, Kohnodai, Chiba, Japan

TEL

0473723501

Homepage URL

http://www.ncgmkohnodai.go.jp/

Email

hhamasaki78@gmail.com


Sponsor or person

Institute

National Center for Global Health and Medicine, Kohnodai Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

National Institutes of Biomedical Innovation, Health and Nutrition

Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center for Global Health and Medicine, Kohnodai Hospital

Address

1-7-1, Kohnodai, Chiba, Japan

Tel

0473723501

Email

dyanai@hospk.ncgm.go.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

国立国際医療研究センター国府台病院


Other administrative information

Date of disclosure of the study information

2016 Year 07 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


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

Open public recruiting

Date of protocol fixation

2016 Year 06 Month 13 Day

Date of IRB

2016 Year 06 Month 06 Day

Anticipated trial start date

2016 Year 07 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Subjects perform walking, floor and window cleaning for 60 minutes per day for 5 days during educational hospitalization of diabetes.
After one to three months of discharge, subjects measure the amount of daily physical activity by a triaxial accelerometer.


Management information

Registered date

2016 Year 06 Month 22 Day

Last modified on

2021 Year 12 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026249


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name