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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01290159
Enrollment
10
Registered
2011-02-04
Start date
2011-05-31
Completion date
2013-07-31
Last updated
2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Heat Stroke

Keywords

tolerance to heat

Brief 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.

Interventions

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.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 28 Years
Healthy volunteers
Yes

Inclusion criteria

for study group: post heat stroke subjects. for control group: healthy subjects matched by age to study group

Exclusion criteria

for control group: any prior heat illness, Diabetes, heart failure, high blood pressure (SBP \>140mmHg), any febrile illness within the last two weeks prior to testing. for study group: Diabetes, heart failure, high blood pressure (SBP \>140mmHg), any febrile illness within the last two weeks prior to testing

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026