UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018335
Receipt number R000021205
Scientific Title The difference of cognitive ability between inpatients with type2 diabetes and individuals without diabetes
Date of disclosure of the study information 2015/07/20
Last modified on 2017/07/20 16:22:40

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Basic information

Public title

The difference of cognitive ability between inpatients with type2 diabetes and individuals without diabetes

Acronym

The difference of cognitive ability between inpatients with type2 diabetes and individuals without diabetes

Scientific Title

The difference of cognitive ability between inpatients with type2 diabetes and individuals without diabetes

Scientific Title:Acronym

The difference of cognitive ability between inpatients with type2 diabetes and individuals without diabetes

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the score of verbal fluency tests between inpatients with type 2 diabetes and individuals witout diabetes.
Verbal fluency tests defined by Troyer in 1997 were adopted.

Basic objectives2

Others

Basic objectives -Others

The influence of type 2 diabetes on cognitive ability

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

We will divide inpatients with type 2 diabetes into 3 groups(A,B,C), by their cognitive ability, and individuals without diabetes into 3 groups(A',B',C') in the same way.
We will compare the score of verbal fluency tests, between A and A', B and B', C and C' each.
GroupA:CDR(clinical dementia rating)=0 and MMSE(Mini-Mental state examination)=30-28,inpatients with type 2 diabetes
GroupB:CDR=0 and MMSE=27-24,inpatients with type 2 diabetes
GroupC:CDR:over 1 and MMSE<24,inpatients with type 2 diabetes
GroupA':CDR=0 and MMSE=30-28,individuals without diabetes
GroupB':CDR=0 and MMSE=27-24,individuals without diabetes
GroupC':CDR:over 1 and MMSE<24,individuals without diabetes

Key secondary outcomes

Subjects are required to carry out the same verbal fluency tests and tapping finger task(tap the right index finger using a counter as quickly as possible) at the same time. We will compare the score of verbal fluency retests, between A and A', B and B', C and C' each.


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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subject:inpatients with type 2 diabetes.
Contorol:individuals without diabetes

Key exclusion criteria

1.The patients with dementias other than Alzheimer disease
2.The patients with history of stroke
3.The patients with psychiatry diseases which may represent cognitive dysfunctions such as depression
4.Diabetic ketoacidosis
5.Thyroid hormone disorders
6.Vitamin deficiency disorders
7.Patients with infectious diseases within 3 months
8.The individuals who stop to generate "the town they have visited" on vebal fluency tests within 1 minute
9.The individuals the attending doctor or the researcher judge inappropriate to be in this study

Target sample size

550


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayo Yamada

Organization

Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations

Division name

Department of Endocrinology & Metabolism

Zip code


Address

Katsura-chou 132, Sakae-ku, Yokohama, Kanagawa, Japan

TEL

045-891-2171

Email

masayo-y@cameo.plala.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taichi Minami

Organization

Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations

Division name

Department of Endocrinology & Metabolism

Zip code


Address

Katsura-chou 132, Sakae-ku, Yokohama, Kanagawa, Japan

TEL

045-891-2171

Homepage URL


Email

ksqdd034@yahoo.co.jp


Sponsor or person

Institute

Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations

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


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



Other administrative information

Date of disclosure of the study information

2015 Year 07 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

Completed

Date of protocol fixation

2014 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 01 Day

Last follow-up date

2017 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

cross-sectional study
The subjects with and without Alzheimer disease will be inpatients with type 2 diabetes in our hospital who agree with the cognitive tests.
The controls without Alzheimer disease will be individuals taking medical checkups in our hospital who agree with the cognitive tests.
The controls with Alzheimer disease will be outpatients with Alzheimer disease in the psychiatry department in our hospital who agree with the cognitive tests.


Management information

Registered date

2015 Year 07 Month 16 Day

Last modified on

2017 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021205


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name