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

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 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

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

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


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