UMIN-CTR Clinical Trial

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

type 2 diabetes

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Juntendo University Graduate School of Medicine

Institute

Department

Personal name

Organization

the Ministry of Health, Labor and Welfare Research Council of Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

06

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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