UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The difference of cognitive ability between inpatients with type2 diabetes and individuals without diabetes
Title of the study (Brief title)	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	Masayo Yamada
Organization	Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
Division name	Department of Endocrinology & Metabolism
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	Taichi Minami
Organization	Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
Division name	Department of Endocrinology & Metabolism
Address	Katsura-chou 132, Sakae-ku, Yokohama, Kanagawa, Japan
TEL	045-891-2171
Homepage URL
Email	ksqdd034@yahoo.co.jp

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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021205