UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034881 |
|---|---|
| Receipt number | 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 22:27:43 |
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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
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
eita-nishimori@umin.ac.jp
Sponsor or person
Institute
Asama General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039681
