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

December 18, 2013 updated by: Prof. Yoram Epstein, Sheba Medical Center

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-10-8150-CM-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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