Tokyo, Jan. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060244) titled 'Blood-based metabolic changes in long-term survivors with chronic carbon monoxide poisoning sequelae' on Jan. 3.

Study Type: Observational

Primary Sponsor: Institute - Kurume University

Condition: Condition - Patients with Chronic Sequelae of Carbon Monoxide Poisoning Classification by malignancy - Others Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 75 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 Size - 30

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068904

Disclaimer: Curated by HT Syndication.