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
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
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
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
