UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047905 |
|---|---|
| Receipt number | R000054617 |
| Scientific Title | Association between personality traits and glycemic control after inpatient diabetes education. |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2023/01/13 09:23:09 |
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Basic information
Public title
Association between personality traits and glycemic control after inpatient diabetes education.
Acronym
Association between personality traits and glycemic control after inpatient diabetes education.
Scientific Title
Association between personality traits and glycemic control after inpatient diabetes education.
Scientific Title:Acronym
Association between personality traits and glycemic control after inpatient diabetes education.
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between personality traits and glycemic control
Basic objectives2
Others
Basic objectives -Others
To clarify the association between personality traits and glycemic control
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the score of each personality trait and the change in HbA1c after discharge from the hospital
Key secondary outcomes
1) Correlation between the scores for each personality trait and the amount of post-discharge weight change
2) Differences in post-discharge HbA1c and weight change among personality traits
3) Correlation between the scores for each personality trait and blood test data at admission
4) Difference in scores for each personality trait between the first and sixth month
5) Changes in blood glucose, HbA1c, and body weight after discharge compared to admission
6) Changes in diabetes medications after discharge compared to admission
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) Patients who are 20 years of age or older at the time of obtaining consent
(2) Patients diagnosed with diabetes mellitus
(3) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding.
Key exclusion criteria
(1) Blind patients
(2) Patients with moderate to severe cognitive dysfunction
(3) Patients with moderate to severe mental disorders (depression, bipolar disorder, schizophrenia, etc.)
(4) Other subjects deemed inappropriate as research subjects by the reserchers.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Horoaki |
| Middle name | |
| Last name | Ueno |
Organization
University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine
Zip code
8891692
Address
5200 Kihara Kiyotake, Miyazaki 889-1692 Japan
TEL
0985851510
taisuke_uchida@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Uchida |
Organization
University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine
Zip code
8891692
Address
5200 Kihara Kiyotake, Miyazaki 889-1692 Japan
TEL
0985851510
Homepage URL
taisuke_uchida@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara Kiyotake, Miyazaki 889-1692 Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-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
| 2022 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
117
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2022 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054617
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
