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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011073
Receipt No. R000012962
Scientific Title The relationships between olfaction and cognitive function in aged patients with type 2 diabetes mellitus
Date of disclosure of the study information 2013/06/29
Last modified on 2014/08/28

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Basic information
Public title The relationships between olfaction and
cognitive function in aged patients with type 2 diabetes mellitus
Acronym The relationships between olfaction and
cognitive function in aged patients with type 2 diabetes mellitus
Scientific Title The relationships between olfaction and
cognitive function in aged patients with type 2 diabetes mellitus
Scientific Title:Acronym The relationships between olfaction and
cognitive function in aged patients with type 2 diabetes mellitus
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated a cross-sectional study on the correlation between olfactory dysfunction and cognitive dysfunction in aged patients with type 2 diabetes. Furthermore, we performed 5 years prospective study to evaluate whether olfactory dysfunction appears prior to cognitive dysfunction in the cases that have not shown cognitive dysfunction at baseline.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incident of cognitive impairment
Key secondary outcomes 1)olfaction
2)metabolic parameters
3)3 complications of diabetes
(retinopathy nephropathy neuropathy)
4)depressive state
5)physical activity
6)preference survey
7)schooling history
8)treatment status
9)past history
10) nutrition assessment


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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients those over age 65 years with type 2 diabetes ,and those who return for follow-up visit


2) Written consent for participation in the study
3) patients who are free of clinically-evident cognitive impairment
Key exclusion criteria Patients meeting one of the following conditions will be excluded
1) patients with severe infections within the preceding 2 weeks,
2) patients scheduled for surgery or who had undergone surgery within the preceding 6 months,
3) patients with severe trauma,
4) patients with psychiatric disorders, 5) patients with hypothyroidism,
6) patients with partial or complete olfactory dysfunction associated with sinusitis, allergic rhinitis, and deviated nasal septum,
7) patients with history of brain tumors, 8) patients on steroid treatment,
9) patients with a MMSE score of less than 18 points
10) patients who were considered ineligible based on the assessment of clinical investigators.

Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruna Sanke
Organization Juntendo University Graduate School of Medicine
Division name Department of Metabolism and Endocrinology
Zip code
Address 2-1-1 Hongo, Bunkyo-KU, Tokyo
TEL 0338133111
Email haruna@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruna Sanke
Organization Juntendo University Graduate School of Medicine
Division name Department of Metabolism and Endocrinology
Zip code
Address 2-1-1 Hongo, Bunkyo-KU, Tokyo
TEL 03-3813-3111
Homepage URL
Email haruna@juntendo.ac.jp

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization the Ministry of Health, Labor and Welfare Research Council of Japan
Organization
Division
Category of Funding Organization
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
2013 Year 06 Month 29 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 Enrolling by invitation
Date of protocol fixation
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We performed a cross-sectional study on the correlation between impaired sense of smell and cognitive dysfunction in aged patients with type II diabetes. Furthermore, we performed 5 years prospective study to evaluate whether impaired sense of smell appears prior to cognitive dysfunction in the cases that have not shown cognitive dysfunction at baseline.

Management information
Registered date
2013 Year 06 Month 29 Day
Last modified on
2014 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012962

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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