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

NCT ID: NCT01290159

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heat Stroke Healthy

Keywords

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tolerance to heat

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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post heat stroke heat tolerant

heat tolerance test (HTT)

Intervention Type OTHER

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.

post heat stroke heat intolerant

heat tolerance test (HTT)

Intervention Type OTHER

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.

healthy controls

heat tolerance test (HTT)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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heat strain

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Yoram Epstein

Heller institue, Sheba Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoram Epstein, PhD

Role: STUDY_DIRECTOR

Heller Institute of Medical Research, Sheba Medical Center, Tel Hashomer

Amit Druyan, MD

Role: PRINCIPAL_INVESTIGATOR

Heller Institute of Medical Research, Sheba Medical Center

Locations

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Heller Institute of Medical Research, Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-10-8150-CM-CTIL

Identifier Type: -

Identifier Source: org_study_id