UMIN-ICDS 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

Email

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


Email

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

Email

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/icdr_e/ctr_view.cgi?recptno=R000038999


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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