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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038439
Receipt No. 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 2019/10/30

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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
Email 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
Email kobayashiyu-int@h.u-tokyo.ac.jp

Sponsor
Institute University of Tokyo Hospital
Institute
Department

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
Email 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 No longer recruiting
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
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2019 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043801

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/11/06 入院中対象患者のみ【操作禁止】.xlsx


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