Clinical Trial

Evaluation of Essential Metal Metabolism

Study acronym: META-GCA
Active, Not Recruiting
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Record status
This record was last updated April 9, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
Disturbance of consciousness (DoC) is a state in which consciousness is altered following brain damage and can manifest in several conditions that result from the loss of regulation of the neural function of the two components of consciousness, alertness and awareness. It is known that the main causes of disorders of consciousness have important effects on the disruption of essential metal homeostasis. In particular, myocardial infarction and heart failure, ischemic and hemorrhagic stroke and head trauma trigger phenomena of diffuse axonal damage, hypoxia and re-perfusion that profoundly alter the metabolism of cerebral O2 that reacts with essential metals , in Fenton-type reactions whose predominant effect is an extensive production of reactive oxygen species (ROS) and pro-oxidant molecules. Fe, Cu and zinc (Zn) are essential metals for life: two thirds of the proteins in our body use these metals that play a crucial role as catalysts or structural elements of proteins in various biological processes, such as cellular respiration in mitochondria, the production and maturation of red and white blood cells, the elasticity of connective tissue, the production of myelin and the production of some neurotransmitters. For this reason, the biology of essential metals has a major impact on our health and the disruption of their homeostasis inexorably leads to disease. These metals are very important for the metabolism of the Central Nervous System (CNS) and Cu, in particular, even in adults, is involved in the production of myelin and in the production of some neurotransmitters of the diffuse modulatory systems . Cu is a cofactor of the enzymes dopamine β-hydroxylase, and monoamine oxidase involved in the balance of catecholamines , and is altered in some disorders of Cu metabolism.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-28.
Trial Details
NCT Number NCT06911515
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Disturbance of Consciousness, Alteration of Metabolism, Essential Metals
Enrollment 120 participants
Start Date 2025-03-17
Primary Completion 2026-03-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-09