Evaluation of Essential Metal Metabolism

Condition(s) studied

Investigational drug(s) / intervention(s)

peripheral venous blood samples, these will be performed in order to measure the biological markers in the serum: peripheral venous blood samples, these will be performed in order to measure the biological markers in the serum

Study 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.

Eligibility

Primary outcome measure(s)

• Blood concetration of essential metal in patients with acquired brain injury — Changes from baseline (T0), after 30 days of treatment (T1)
  Quantification of blood essential metal levels in peripheral venous blood samples in patients with acquired brain injury (Fe, range: Men: 65-178 µg/dL, Women: 50-170 µg/dL; Zn, range: 75- 110 µg/dL; Cu, range: Men: 60-160 µg/dL, Women: 80-155 µg/dL;non-Cp Cu, range: less than 5 µg/dL) compared to healthy patients.

Trial sites (1)

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy