UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034208 |
|---|---|
| Receipt number | R000038999 |
| Scientific Title | Association between executive function tests scores and glycemic controls in one year after hospitalization. |
| Date of disclosure of the study information | 2018/09/20 |
| Last modified on | 2023/10/10 11:43:55 |
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Basic information
Public title
Association between executive function tests scores and glycemic controls in one year after hospitalization.
Acronym
Association between executive function tests scores and glycemic controls in one year after hospitalization.
Scientific Title
Association between executive function tests scores and glycemic controls in one year after hospitalization.
Scientific Title:Acronym
Association between executive function tests scores and glycemic controls in one year after hospitalization.
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationships between executive function test z-scores and HbA1c levels in one year after hospitalization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will evaluate executive function (mentioned below) of T2DM patients. We will divide all patients into two groups by the median executive function z-score. We will compare HbA1c levels in one year after hospitalization between patients who show the better and worse scores.
Key secondary outcomes
We will investigate the effects on metabolic markers of executive function z-scores in the hospital: metabolic markers are QOL test scores,self-efficacy test scores, geriatric depression scale scores,lipid indices,BMI, polypharmacy, Insulin usage, days of over 30 min exercise habits per week, comorbidities of diabetes in one year after hospitalization, using multiple regression analysis.
We will evaluate the relationships between executive function z-scores during the hospitalization and HbA1c levels in one year after hospitalization with and without adjusting for Japanese diabetes knowledge test (JDKT) scores.
If we administer some of patients JDKT and executive function tests, we will assess changes of the scores.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aged 65 years or older, type 2 diabetes, diabetes duration within 5 years, the first time of hospitalization required for glycemic controls
Key exclusion criteria
Dementia,stroke,psychiatric conditions,such as depression, schizophrenia,developmental disorder,or attention deficit-hyperactivity disorder, diabetic ketoacidosis, patients who were unable to recall places they had visited within 1 min,steroid users
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Minami |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
2348503
Address
3-2-10,Konandai Konan-ku, Yokohama City, kanagawa 234-0054,Japan
TEL
045-832-1111
Amadeus@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Hiiragi |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
2348503
Address
3-2-10,Konandai Konan-ku, Yokohama City, kanagawa 234-0054,Japan
TEL
045-832-1111
Homepage URL
hiiragihiroko@gmail.com
Sponsor or person
Institute
Saiseikai Yokohamashi Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Odawara Municipal Hospital,Yokoham Sakae Kyosai Hospital,Minagawa Medical Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Yokohamashi Nanbu Hospital
Address
3-2-10,Konan-ku Yokohama City, Kanagawa 234-0054,Japan
Tel
045-832-1111
soumu01@nanbu.saiseikai.or.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
済生会横浜市南部病院（神奈川県）/Saiseikai Yokohamashi Nanbu Hospital(Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 30 | Day |
Other
Other related information
Longitudinal study
We will undergo three cognitive tests to assess executive function of T2DM inpatients. The tests are 1. a verbal fluency test (animal names) with tapping, 2. Trail making test B, 3. Stroop test (Hakoda, number4).
Then we will standardize each cognitive test score and define mean standardized three cognitive tests scores as executive function z-scores. We will divide all T2DM inpatients into two groups by the median executive function z-score. Besides, we will compare the differences of HbA1c levels in one year after hospitalization between patients with better and those with worse executive function z-scores.
When better executive function result in better HbA1c levels in one year after hospitalization. We will also investigate the reasons; diabetes knowledge test scores, QOL test scores, geriatric depression scale scores, self-efficacy test scores, BMI, days of over 30 min exercise habits per week, comorbidities of diabetes in one year after hospitalization, using multiple regression analysis.
We will use Japanese diabetes knowledge test to assess knowledge. URL: http://www.city.odawara.kanagawa.jp/global-image/units/358806/1-20180807183200.pdf
Management information
Registered date
| 2018 | Year | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038999
