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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022833
Receipt No. 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 2019/06/25

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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
Institute National Center for Global Health and Medicine, Kohnodai Hospital
Institute
Department

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
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
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
2019 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.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


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