UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022538 |
|---|---|
| Receipt number | 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 09:27:05 |
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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
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
ohkura@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Faculty of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025823
