UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052252 |
|---|---|
| Receipt number | R000059647 |
| Scientific Title | Examining the association between mitochondrial dysfunction and indeterminate physical complaints |
| Date of disclosure of the study information | 2023/09/20 |
| Last modified on | 2024/08/14 10:26:30 |
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Basic information
Public title
Examining the association between mitochondrial dysfunction and indeterminate physical complaints
Acronym
Mitochondrial dysfunction and indeterminate complaints
Scientific Title
Examining the association between mitochondrial dysfunction and indeterminate physical complaints
Scientific Title:Acronym
Mitochondrial dysfunction and indeterminate physical complaints
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between mitochondrial dysfunction and indeterminate physical complaints.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To analyse the data of the iwaki Health Promotion Project in 2022.
To determine the association between the degree of indeterminate physical complaints and blood GDF15.
Key secondary outcomes
Exploratory analysis of the relationship between GDF15 and other tests than indeterminate physical complaints.
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
Men and women aged 20 years and over who participated in the 2022 Iwaki health promotion project.
Those who live in the Iwaki area of Hirosaki City, Aomori Prefecture.
Key exclusion criteria
1) Those with missing GDF15 data.
2) Those with missing questionnaire data on indeterminate complaints.
3) Subjects who are judged unsuitable for this trial by the principal investigator.
Target sample size
730
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Itoh |
Organization
Hirosaki University
Division name
Department of Stress Response Science, Graduate School of Medicine
Zip code
036-8562
Address
5-Zaifu-cho Hirosaki, Aomori 036-8562, Japan
TEL
0172-39-5157
Itohk@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Itoh |
Organization
Hirosaki university
Division name
Department of Stress Response Science, Graduate School of Medicine
Zip code
036-8562
Address
5-Zaifu-cho Hirosaki, Aomori 036-8562, Japan
TEL
0172-39-5157
Homepage URL
Itohk@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
Funding Source
Organization
KAGOME Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Hirosaki University Graduate School of Medicine
Address
5-Zaifu-cho Hirosaki, Aomori 036-8562, Japan
Tel
0172-39-5044
rinri@hirosaki-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the association between reduced mitochondrial function and indeterminate physical complaints using data from health examinations in 2022 of Japanese adult men and women living in the Iwaki area of Hirosaki City, Aomori Prefecture, Japan.
Management information
Registered date
| 2023 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059647
