UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046635
Receipt number R000053201
Scientific Title The relationship between thyroid function and metabolic syndrome through the medical checkup in Japan: A retrospective cohort study
Date of disclosure of the study information 2022/01/14
Last modified on 2023/01/18 13:48:27

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Basic information

Public title

The relationship between thyroid function and metabolic syndrome through the medical checkup in Japan

Acronym

The relationship between thyroid function and metabolic syndrome through the medical checkup in Japan

Scientific Title

The relationship between thyroid function and metabolic syndrome through the medical checkup in Japan: A retrospective cohort study

Scientific Title:Acronym

The relationship between thyroid function and metabolic syndrome through the medical checkup in Japan: A retrospective cohort study

Region

Japan


Condition

Condition

Metabolic syndrome

Classification by specialty

Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the relationship between thyroid function and metabolic syndrome in a Japanese population.

Basic objectives2

Others

Basic objectives -Others

To investigate the relationship between thyroid function and metabolic disorders

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The relationship between thyroid function and metabolic disorders, such as hypertension, dyslipidemia, diabetes, NAFLD and hyperuricemia

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

People undergoing thyroid function tests as part of medical checkup at the Jikei University Shinbashi Medical Examination Center and Harumi Triton Clinic Health Care Center, Tokyo, Japan, between April 2013 and August 2021

Key exclusion criteria

People who refuse to participate in the study

Target sample size

900


Research contact person

Name of lead principal investigator

1st name Yui
Middle name
Last name Watanabe

Organization

The Jikei University School of Medicine

Division name

Division of Diabetes, Metabolism and Endocrinology

Zip code

105-8461

Address

3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, Japan

TEL

0334331111

Email

y.hattori@jikei.ac.jp


Public contact

Name of contact person

1st name Yui
Middle name
Last name Watanabe

Organization

The Jikei University School of Medicine

Division name

Division of Diabetes, Metabolism and Endocrinology

Zip code

105-8461

Address

3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, Japan

TEL

0334331111

Homepage URL


Email

y.hattori@jikei.ac.jp


Sponsor or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Human Subjects Committee of the Jikei University School of Medicine

Address

3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, Japan

Tel

0334331111

Email

rinri@jikei.ac.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

東京慈恵会医科大学附属新橋健診センター(東京都)、慈恵医大晴海トリトンクリニック晴海健診センター(東京都)


Other administrative information

Date of disclosure of the study information

2022 Year 01 Month 14 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

No longer recruiting

Date of protocol fixation

2021 Year 11 Month 01 Day

Date of IRB

2021 Year 11 Month 01 Day

Anticipated trial start date

2022 Year 01 Month 14 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We retrospectively evaluated the relationship between thyroid function and metabolic disorder in a Japanese population by using the results of medical checkup.


Management information

Registered date

2022 Year 01 Month 14 Day

Last modified on

2023 Year 01 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053201


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name