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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035935
Receipt No. R000040932
Scientific Title The Effects of Non-exercise Activity Thermogenesis (NEAT) on Metabolic Parameters in Patients with Type 2 Diabetes
Date of disclosure of the study information 2019/02/19
Last modified on 2019/08/21

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Basic information
Public title The Effects of Non-exercise Activity Thermogenesis (NEAT) on Metabolic Parameters in Patients with Type 2 Diabetes
Acronym The Effects of Non-exercise Activity Thermogenesis (NEAT) on Metabolic Parameters in Patients with Type 2 Diabetes
Scientific Title The Effects of Non-exercise Activity Thermogenesis (NEAT) on Metabolic Parameters in Patients with Type 2 Diabetes
Scientific Title:Acronym The Effects of Non-exercise Activity Thermogenesis (NEAT) on Metabolic Parameters in Patients with Type 2 Diabetes
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the influences of Non-exercise activity thermogenesis(NEAT) on glucose or lipid metabolisms, blood pressure and body composition
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes of metabolic parameters and body composition during the term of exercise similar to NEAT or the term of absence of exercise during hospitalization
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Exercise similar to NEAT
Interventions/Control_2 Absence of exercise
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 Patients with type 2 diabetes who are hospitalized
Key exclusion criteria - Patients in emergent state like diabetic ketoacidosis or Hyperosmolar hyperglycemic state
- Patients who have difficulties in the activities of daily living
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisayuki Katsuyama
Organization National Center for Global Health and Medicine Kohnodai Hospital
Division name Department of Internal Medicine
Zip code
Address 1-7-1 Kohnodai, Ichikawa-city, Chiba, Japan
TEL +81-47-372-3501
Email katsuyama-hs@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisayuki Katsuyama
Organization National Center for Global Health and Medicine Kohnodai Hospital
Division name Department of Internal Medicine
Zip code
Address 1-7-1 Kohnodai, Ichikawa-city, Chiba, Japan
TEL +81-47-372-3501
Homepage URL
Email katsuyama-hs@umin.ac.jp

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

Funding Source
Organization National Center for Global Health and Medicine Kohnodai Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 19 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 21 Day
Date of IRB
2016 Year 06 Month 20 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 19 Day
Last modified on
2019 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040932

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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