UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on improvement of eating habits of diabetic patients
Title of the study (Brief title)	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	Eita Nishimori
Organization	Asama General Hospital
Division name	diabetes medicine
Address	1862-1 Iwamurada, Saku, Nagano
TEL	0267-67-2295
Email	eita-nishimori@umin.ac.jp

Public contact
Name of contact person	Eita Nishimori
Organization	Asama General Hospital
Division name	diabetes medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 10 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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