UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011073
Receipt number 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 10:07:28

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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 or person

Institute

Juntendo University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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