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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034881
Receipt No. R000039681
Scientific Title Study on improvement of eating habits of diabetic patients
Date of disclosure of the study information 2018/11/13
Last modified on 2018/11/13

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Basic information
Public title Study on improvement of eating habits of diabetic patients
Acronym Diabetes fast eating improvement study
Scientific Title Study on improvement of eating habits of diabetic patients
Scientific Title:Acronym Diabetes fast eating improvement study
Region
Japan

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

Objectives
Narrative objectives1 It aims to examine whether it is possible to extend eating time, increase the number of chewing, and improve postprandial blood glucose by eating with the hand opposite to the dominant hand.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Extension of eating time with reverse handedness
2. Improve postprandial blood glucose with reverse handedness
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Eating with reverse handedness
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Type 2 diabetes patients who are visiting Asama General Hospital
1. Age: 20 years old and over 75 years old (when acquiring consent)
2. Those who got written consent (proxy agreement is not possible)
Key exclusion criteria 1. type 1 diabetic patients
2. Other, those who judged that principal investigator or medical doctor inappropriate
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eita Nishimori
Organization Asama General Hospital
Division name diabetes medicine
Zip code
Address 1862-1 Iwamurada, Saku, Nagano
TEL 0267-67-2295
Email eita-nishimori@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eita Nishimori
Organization Asama General Hospital
Division name diabetes medicine
Zip code
Address 1862-1 Iwamurada, Saku, Nagano
TEL 0267-67-2295
Homepage URL
Email eita-nishimori@umin.ac.jp

Sponsor
Institute Asama General Hospital
Institute
Department

Funding Source
Organization Asama General Hospital
Organization
Division
Category of Funding Organization Other
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 佐久市立国保浅間総合病院

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 13 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
2018 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 13 Day
Last modified on
2018 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039681

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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