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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Heat Stroke
• Intervention / Treatment: Other: heat tolerance test (HTT)

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Israel
  • Tel Hashomer, Israel, 52621
    • Heller Institute of Medical Research, Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

young (18-28 years old) post heat stroke subjects, and matched healthy controls

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy controls	Other: heat 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.; Other Names: heat strain
post heat stroke heat tolerant	Other: heat 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.; Other Names: heat strain
post heat stroke heat intolerant	Other: heat 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.; Other Names: heat strain

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Study Director: Yoram Epstein, PhD, Heller Institute of Medical Research, Sheba Medical Center, Tel Hashomer; Principal Investigator: Amit Druyan, MD, Heller Institute of Medical Research, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 3, 2011
• First Submitted That Met QC Criteria: February 3, 2011
• First Posted (Estimate): February 4, 2011

Study Record Updates

• Last Update Posted (Estimate): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: tolerance to heat
• Additional Relevant MeSH Terms: Wounds and Injuries; Heat Stress Disorders; Heat Stroke
• Other Study ID Numbers: SHEBA-10-8150-CM-CTIL