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
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
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
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
