UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025260
Receipt No. R000029055
Scientific Title Consideration of "Animal test" as screening for dementia and related dementia test in diabetic patients
Date of disclosure of the study information 2016/12/13
Last modified on 2016/12/13

* 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 Consideration of "Animal test" as screening for dementia and related dementia test in diabetic patients
Acronym Consideration of "Animal test" as screening for dementia and related dementia test in diabetic patients
Scientific Title Consideration of "Animal test" as screening for dementia and related dementia test in diabetic patients
Scientific Title:Acronym Consideration of "Animal test" as screening for dementia and related dementia test in diabetic patients
Region
Japan

Condition
Condition Dementia
Classification by specialty
Medicine in general Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We sought to examine the relationship between the the one-minute animal test (OMAT) and the Hasegawa's Dementia Scale-Revised (HDS-R)scores, and determine the cut-off OMAT score that balanced the sensitivity and specificity in identifying HDS-R-positive patients among all patients as well as in the subgroup of patients aged 65 years or older.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the cut-off score of OMAT that balanced the sensitivity closest to 1.00 and enabled the highest specificity for the HDS-R-positive status
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Execute OMAT and HDS-R once each at the time of consultation.
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
40 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Consecutive patients with diabetes who visited the outpatient clinic at Fujiidera Municipal Hospital from January 2014 to June 2015.
Key exclusion criteria Patients who the informed consent was not obtained.
Target sample size 122

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeki Kinuhata
Organization Osaka City University, Graduate School and Faculty of Medicine
Division name Department of General Practice & Medical Education
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL +81-6-6645-3797
Email 3doutor3@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Kinuhata
Organization Osaka City University, Graduate School and Faculty of Medicine
Division name Department of General Practice & Medical Education
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL +81-6-6645-3797
Homepage URL
Email 3doutor3@gmail.com

Sponsor
Institute Osaka City University, Graduate School and Faculty of Medicine
Institute
Department

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
Email

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
2016 Year 12 Month 13 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 01 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
2015 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 13 Day
Last modified on
2016 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029055

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.