UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038439 |
|---|---|
| Receipt number | R000043801 |
| Scientific Title | Investigation of a high-risk group that should be considered for cognitive function testing in diabetes treatment |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2020/05/01 14:01:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Which parameter is specific between normal cognitive function and declined cognitive function in diabetes patients?
Acronym
Which parameter is specific between normal cognitive function and declined cognitive function in diabetes patients?
Scientific Title
Investigation of a high-risk group that should be considered for cognitive function testing in diabetes treatment
Scientific Title:Acronym
Investigation of a high-risk group that should be considered for cognitive function testing in diabetes treatment
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is well known that the risk of cognitive disorder increases in diabetes patients. But, there is no consensus when patients should have a cognitive test or who should have the test. Because a cognitive test takes time, it is difficult to have a cognitive test for all diabetes patients. Searching the clinical parameters distinguished in diabetes patients saves time and effort.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive dysfunction is measured using the Mini Mental State Examination (MMSE) score after getting consent.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients diagnosed with diabetes mellitus, who were admitted to the Department of Diabetes and Metabolic Diseases at The University of Tokyo Hospital between 17/07/2016 and 31/03/2017
Key exclusion criteria
1.Pregnant
2.Lactating
3.Acute organ failure (e.g., pneumonia, acute myocardial infarction, acute cerebral infarction, diabetic ketoacidosis, and hyperosmolar hyperglycemic state)
4.Congenital cognitive disorders
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Medical University Hospital
Division name
Division of Diabetes, Metabolism, Endocrinology, Rheumatology and Collagen Diseases
Zip code
1600023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
ryosuzuki-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Kobayashi |
Organization
University of Tokyo Hospital
Division name
Department of Diabetes and Metabolic Diseases
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0358008815
Homepage URL
kobayashiyu-int@h.u-tokyo.ac.jp
Sponsor or person
Institute
University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical University Ibaraki medical center
Name of secondary funder(s)
The Nakatani Foundation for Advancement of Measuring Technologies in Biomedical Engineering
IRB Contact (For public release)
Organization
Ethics Committee of the University of Tokyo
Address
Office for Human Research Studies (OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Faculty of Medicine Bldg.2 4F 7-3-1
Tel
0358410818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
37130
Org. issuing International ID_1
ISRCTN
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 01 | 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
200
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
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Background and study aims
It is well known that the risk of cognitive disorder increases in diabetes patients, but there is no consensus regarding when patients should have a cognitive test or who should have the test.
Because the cognitive test takes time, it is difficult to have a cognitive test for all diabetes patients. Searching the clinical parameters distinguished in diabetes patient saves time and effort. The aim of this study is to find out whether there is a high-risk group that should be considered for cognitive function testing in diabetes treatment.
Who can participate?
Patients with diabetes who were admitted to the Department of Diabetes and Metabolic Diseases at The University of Tokyo Hospital between 17/07/2016 and 31/03/2017.
What does the study involve?
Patient information is collected on the day of hospitalization and fasting blood samples are collected soon after obtaining informed consent.
What are the possible benefits and risks of participating?
The benefit is if the MMSE score has declined, the patient can have a medical examination of cognitive function, and can have treatment as quickly as possible. The risk is bleeding from blood collection.
Management information
Registered date
| 2019 | Year | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043801
