UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060244 |
|---|---|
| Receipt number | R000068904 |
| Scientific Title | Serum Metabolomic Signature and Brain-Derived Neurotrophic Factor in Long Term Survivors with Chronic Sequelae of Carbon Monoxide Poisoning 60 Years after the Miike Mikawa Coal Mine Disaster: A Cross-Sectional Case Control Study |
| Date of disclosure of the study information | 2026/01/03 |
| Last modified on | 2026/01/02 14:12:50 |
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Basic information
Public title
Blood-based metabolic changes in long-term survivors with chronic carbon monoxide poisoning sequelae
Acronym
CO-BLOOD
Scientific Title
Serum Metabolomic Signature and Brain-Derived Neurotrophic Factor in Long Term Survivors with Chronic Sequelae of Carbon Monoxide Poisoning 60 Years after the Miike Mikawa Coal Mine Disaster: A Cross-Sectional Case Control Study
Scientific Title:Acronym
MIKE-CO60
Region
| Japan |
Condition
Condition
Patients with Chronic Sequelae of Carbon Monoxide Poisoning
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Neurosurgery | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize serum metabolite profiles in older long-term survivors with chronic sequelae of carbon monoxide (CO) poisoning approximately 60 years after the Miike Mikawa coal mine disaster, and to examine whether these profiles differ from those of non-exposed former coal miners, with exploratory assessment of associations with cognitive and functional measures.
Basic objectives2
Others
Basic objectives -Others
To exploratorily characterize inter-metabolite correlation patterns among the predefined key metabolites measured by targeted serum metabolomics (e.g., valine, alanine, betaine, 3-hydroxybutyric acid, inosine, and hypoxanthine).
To exploratorily assess correlations between the predefined key metabolites and physical/cognitive functional measures (e.g., FIM-cognitive, LSA, MMSE, CBA, TMT-B, BMI, and SMI).
To exploratorily evaluate the robustness of key between-group metabolite differences using age-matched propensity-score matching (1:1) as a sensitivity analysis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Between-group differences (CO vs. CON) in serum concentrations of the predefined key metabolites measured by targeted metabolomics
Key secondary outcomes
Inter-metabolite correlations among the predefined key metabolites measured by targeted serum metabolomics.
Correlations between the predefined key metabolites and physical/cognitive functional measures (e.g., FIM-cognitive, LSA, MMSE, CBA, TMT-B, BMI, SMI).
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
| 75 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
Age >= 75 years at enrollment.
Former coal miners who worked at the Miike-Mikawa coal mine (Omuta, Japan) around the time of the 9 November 1963 coal dust explosion.
CO group: Outpatients with chronic sequelae of carbon monoxide (CO) poisoning accompanied by higher brain dysfunction and followed under the workers' compensation-based aftercare program.
Control (CON) group: Former miners from the same mine with no disaster-related CO exposure and not followed for CO-poisoning sequelae.
Key exclusion criteria
Neuropsychiatric disorders not attributable to CO-poisoning sequelae.
History of cerebrovascular disease with evident residual paralysis and/or persistent cognitive impairment.
For the serum metabolomics analysis subset: current use of medications that could materially affect energy metabolism, including (a) antidiabetic agents, (b) thyroid-related medications (thyroid hormone replacement or antithyroid drugs), or (c) systemic oral corticosteroids.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Matsuse |
Organization
Kurume University
Division name
Rehabilitation center
Zip code
8300011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942353311
matsuse_hiroh@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Imafuku |
Organization
Kurume University
Division name
Industry Academia Government Collaboration Promotion Office, Department of Strategic Planning
Zip code
8300011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
08049057194
Homepage URL
sangaku@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Hiroo Matsuse
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kurume University health care & medical ethics
Address
67 Asahi-machi, Kurume, Fukuoka
Tel
0942353311
i_rinri@kurume-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
| 2026 | Year | 01 | Month | 03 | 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
30
Results
Targeted serum metabolomics identified a consistent pattern in the CO group: higher amino acid-related metabolites (e.g., valine, alanine, betaine) together with lower 3-hydroxybutyric acid (a ketone body) and lower purine-related metabolites (e.g., inosine and hypoxanthine). These differences for the six key metabolites (valine, alanine, betaine, 3-hydroxybutyric acid, inosine, and hypoxanthine) were generally preserved in an age-matched sensitivity analysis (propensity-score matching).
Results date posted
| 2026 | Year | 01 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The analysis included 14 participants in the CO group and 16 in the control (CON) group (all aged >= 75 years).
Age, BMI, and SMI were broadly comparable between groups.
Compared with controls, the CO group showed worse cognitive and functional status, with lower MMSE, FIM-cognitive, LSA, and CBA scores and longer TMT-B completion times.
Serum BDNF showed a lower direction in the CO group.
Participant flow
CO group: Potential participants were identified from outpatients followed under the workers' compensation-based aftercare program for chronic CO-poisoning sequelae and were enrolled after eligibility confirmation.
Control (CON) group: Former miners from the same mine without disaster-related CO exposure were contacted based on a roster and enrolled after eligibility confirmation.
For serum metabolomics, the analytic cohort was derived from the same participant pool as our prior study; individuals taking medications that could materially affect energy metabolism (antidiabetic agents, thyroid-related medications, or systemic oral corticosteroids) were excluded, yielding 14 CO and 16 CON participants for analysis.
As a sensitivity analysis, age-matched propensity-score matching (1:1) was performed, and the matched analysis included 9 CO and 9 CON participants.
Adverse events
N/A
Outcome measures
Targeted serum metabolite concentrations
Cognitive/functional measures: FIM-cognitive, LSA, MMSE, CBA, TMT-B
Body composition/anthropometrics: BMI, SMI, CMI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
This is an observational, cross-sectional study based on a fixed-point (periodic) survey conducted approximately 60 years after the 1963 Miike-Mikawa coal mine disaster. Former coal miners were identified from periodic post-disaster surveys and long-term follow-up records, and were classified into a CO-poisoning sequelae group and a non-exposed control group. At a single study visit, serum samples and clinical assessments (cognitive and functional measures) were obtained, and targeted serum metabolomics was performed for between-group comparisons and exploratory association analyses.
Management information
Registered date
| 2026 | Year | 01 | Month | 02 | Day |
Last modified on
| 2026 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068904
