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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022538
Receipt No. R000025823
Scientific Title Investigation into character type and dietary behavior-related factor of the patients with diabetes mellitus
Date of disclosure of the study information 2016/06/01
Last modified on 2021/03/01

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Basic information
Public title Investigation into character type and dietary behavior-related factor of the patients with diabetes mellitus
Acronym Investigation into character type and dietary behavior-related factor of the patients with diabetes mellitus
Scientific Title Investigation into character type and dietary behavior-related factor of the patients with diabetes mellitus
Scientific Title:Acronym Investigation into character type and dietary behavior-related factor of the patients with diabetes mellitus
Region
Japan

Condition
Condition diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 This study attempts to examine the effectiveness in undergoing medical treatment and instructing based on the character type and dietary behavior of the patients with diabetes mellitus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c of the patient two years after leaving the hospital,who was hospitalized for education of diabetes mellitus.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)The patient who needs hospitalization for education of diabetes mellitus in the Tottori University Hospital
2)20 years old or older
3)The patient who can answer a questionnaire by himself/herself
4)The patient whose consent to participation in this study we can obtain from himself/herself
Key exclusion criteria 1)The patient with the mental disease
2)The patient who the attending physician
judges is medically inappropriate to participate in this study
3)Secondary diabetes
4)Pregnant women
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Okura
Organization Tottori University Faculty of medicine
Division name Division of Cardiovascular Medicine and Endocrinology and Metabolism
Zip code 683-8504
Address 36-1,Nishi-cho Yonago-shi, Tottori
TEL 0859-38-6517
Email ohkura@tottori-u.ac.jp

Public contact
Name of contact person
1st name Tsuyoshi
Middle name
Last name Okura
Organization Tottori University Faculty of medicine
Division name Division of Cardiovascular Medicine and Endocrinology and Metabolism
Zip code 683-8504
Address 36-1,Nishi-cho Yonago-shi, Tottori
TEL 0859-38-6517
Homepage URL
Email ohkura@tottori-u.ac.jp

Sponsor
Institute Tottori University Faculty of medicine
Institute
Department

Funding Source
Organization MSD K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Clinical Intervention Research Ethics Committee of Tottori University Hospital
Address 36-1,Nishi-cho Yonago-shi, Tottori
Tel 0859-38-6946
Email crsc@ml.med.tottori-u.ac.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

Other administrative information
Date of disclosure of the study information
2016 Year 06 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 Enrolling by invitation
Date of protocol fixation
2016 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 06 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 This study is a prospective study.
An observation period in this study will be two years.
We analyze the relation between the character type,dietary behavior-related factor, adherence, and glycemic control.

Management information
Registered date
2016 Year 05 Month 30 Day
Last modified on
2021 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025823

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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