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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034208
Receipt No. 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 2019/04/03

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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
Middle name
Last name Uru Nezu Osada
Organization Saiseikai Yokohamashi Nanbu Hospital
Division name Diabetes and Endocrinology
Zip code
Address 3-2-10,Konandai Konan-ku, Yokohama City, kanagawa 234-0054,Japan
TEL 045-832-1111
Email Amadeus@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Hiiragi
Organization Saiseikai Yokohamashi Nanbu Hospital
Division name Diabetes and Endocrinology
Zip code
Address 3-2-10,Konandai Konan-ku, Yokohama City, kanagawa 234-0054,Japan
TEL 045-832-1111
Homepage URL
Email hiiragihiroko@gmail.com

Sponsor
Institute Saiseikai Yokohamashi Nanbu Hospital
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
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
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038999

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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