UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between cognitive function and thyroid function in Japanese elders
Acronym	Cognitive function and thyroid function in Japanese elders
Scientific Title	The relationship between cognitive function and thyroid function in Japanese elders
Scientific Title:Acronym	Cognitive function and thyroid function in Japanese elders
Region	Japan

Condition
Condition	Dementia, Thyroid dysfunction
Classification by specialty	Endocrinology and Metabolism Geriatrics Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Survey the relationship between cognitive function and thyroid function in Japanese elders
Basic objectives2	Others
Basic objectives -Others	Determine the refference range of thyroid function in Japanese elders
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between cognitive function and thyroid function in Japanese elders
Key secondary outcomes	Refference range of thyroid function in Japanese elders

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	60 years-old <=
Age-upper limit	120 years-old >
Gender	Male and Female
Key inclusion criteria	without known thyroid disease
Key exclusion criteria	with known thyroid disease
Target sample size	999

Research contact person
Name of lead principal investigator	1st name Sumiko Middle name Last name Kato
Organization	Osaka Saiseikai Ibaraki Hospital
Division name	Department of Diabetes mellitus and endocrinology
Zip code	567-0035
Address	2-1-45 Mitsukeyama, Ibaraki-shi, Osaka, Japan
TEL	072-622-8651
Email	s.katou@ibaraki.saiseikai.or.jp

Public contact
Name of contact person	1st name Sumiko Middle name Last name Kato
Organization	Osaka Saiseikai Ibaraki Hospital
Division name	Department of Diabetes mellitus and endocrinology
Zip code	567-0035
Address	2-1-45 Mitsukeyama, Ibaraki-shi, Osaka, Japan
TEL	072-622-8651
Homepage URL
Email	s.katou@ibaraki.saiseikai.or.jp

Sponsor
Institute	Department of Diabetes mellitus and Endocrinology, Osaka Saiseikai Ibaraki Hospital
Institute
Department

Funding Source
Organization	Metabolic and Obese Research Institute
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB
Address	2-1-45 Mitsukeyama, Ibaraki-shi, Osaka, Japan
Tel	072-622-8651
Email	a.ioi@ibaraki.saiseikai.or.jp

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	社会福祉法人　恩賜財団　大阪府済生会茨木病院（大阪府） 独立行政法人　国立病院機構　京都医療センター（京都府） 社会福祉法人　恩賜財団　大阪府済生会中津病院（大阪府） 独立行政法人　東京都長寿健康医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 24 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1070
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	delay to input
Date of the first journal publication of results	2022 Year 03 Month 19 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 09 Month 07 Day
Date of IRB	2017 Year 04 Month 18 Day
Anticipated trial start date	2017 Year 11 Month 24 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry	2020 Year 10 Month 30 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information	cross-sectional study

Management information
Registered date	2017 Year 11 Month 22 Day
Last modified on	2022 Year 04 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034340