UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018337 |
|---|---|
| Receipt number | R000021224 |
| Scientific Title | The effect of long-term bad glycemic control on cognitive ability of patients with type2 diabetes |
| Date of disclosure of the study information | 2015/07/21 |
| Last modified on | 2017/01/27 10:37:49 |
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Basic information
Public title
The effect of long-term bad glycemic control on cognitive ability of patients with type2 diabetes
Acronym
The effect of long-term bad glycemic control on cognitive ability of patients with type2 diabetes
Scientific Title
The effect of long-term bad glycemic control on cognitive ability of patients with type2 diabetes
Scientific Title:Acronym
The effect of long-term bad glycemic control on cognitive ability of patients with type2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analogize the influence of bad long-term glycemic control on cognitive ability in type 2 diabetes.
Basic objectives2
Others
Basic objectives -Others
Defining the time-weighed average HbA1c as each HbA1c measurement*intervals/total time, we will validate the relationships between the time-weighed average HbA1c and the scores of cognitive ability tests.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between the time-weighed average HbA1c(during1, 3, 5,10 years each) and results of cognitive ability examinations.
The relationship between HbA1c values when cognitive examinations are required and results of the examinations.
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. The relationship between the time-weighed average HbA1c(during1,3,5,10 years each) and results of the re-examinations are investigated.
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
1.Patients with type 2 diabetes
2.HbA1c values can be followed for over 5 years
Key exclusion criteria
1.The patients with dementias other than AD
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.Patients with infectious diseases within 3 months
6.The individuals who stop to generate "the town they have visited" on VF within 1 minute
7.The individuals the attending doctor or the researcher judge inappropriate to be in this study
Target sample size
200
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
Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
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
国家公務員共済組合連合会横浜栄共済病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 21 | 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
| 2016 | Year | 06 | 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 will be patients with type 2 diabetes in our hospital and Minagawanaika clinic(Medical corporation Taijyukai) who agree with the cognitive tests.
There will be no controls.
Management information
Registered date
| 2015 | Year | 07 | Month | 16 | Day |
Last modified on
| 2017 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021224
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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