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CompletedNCT01290159

The Development Of A Novel Biomarker For Early Identification Of The Individual's State Of Tolerance To Heat

Preliminary Study of Identifying the Tolerance to Heat by a Novel Biomarker of Oxidative Stress

Status
Completed
Phase
Study type
Observational
Enrollment
10 (actual)
Sponsor
Sheba Medical Center · Other Government
Sex
Male
Age
18 Years – 28 Years
Healthy volunteers
Accepted

Summary

Today, the level of tolerance to heat is based on physiological strain indices, with no correlates to any relevant biomarker. We hypothesize that oxidative stress (OS) and the formation of reactive oxygen and nitrogen species (ROS, RNS), which are part of the underling pathophysiology related to hyperthermia, can be used to identify tolerance/intolerance to heat. The aim of the present project is to develop a simple assay, based on specific designed sensitive biomarkers of OS that can be detected in a small blood sample, and to possibly correlate each individual's state of tolerance to heat to the level of OS. These biomarkers specially designed and synthesized to form a novel probe (not present as such in biological organs). The method will be based on the incubation of the suggested biomarkers with the patient's blood sample and the measurement of the level and type of oxidative alteration of the markers. For this goal, post heat stroke patients, with different levels of tolerance to heat and subjects during a process of acclimation to heat will be studied. Such a method will add to our ability to better determine the level of tolerance to heat and not rely only on the measurements of temperature and heart rate during an exercise-heat stress.

Conditions

Interventions

TypeNameDescription
OTHERheat tolerance test (HTT)An exercise-heat test,which consists of 120 min exposure to walking on a treadmill (5km/h; 2% grade) under conditions of 40oC and 50% rh.

Timeline

Start date
2011-05-01
Primary completion
2013-04-01
Completion
2013-07-01
First posted
2011-02-04
Last updated
2013-12-19

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT01290159. Inclusion in this directory is not an endorsement.