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CompletedNCT01290159Updated Dec 19, 2013

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

An observational study in Heat Stroke and Healthy, sponsored by Sheba Medical Center. Completed at 1 site in Israel. Open to male participants aged 18 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-19.

Sponsored by Sheba Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 28 Years
Sex
Male
01

Study 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.

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Conditions studied

  • Heat Stroke
  • Healthy

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Keywords

  • tolerance to heat
03

In context

Heat Stroke

21 studies on the registry are indexed under Heat Stroke; 10 are open to participants now.

Browse Heat Stroke studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 28 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)

Groups and cohorts

  • post heat stroke heat tolerant

    Other: heat tolerance test (HTT)

  • post heat stroke heat intolerant

    Other: heat tolerance test (HTT)

  • healthy controls

    Other: heat tolerance test (HTT)

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.

    Also known as: heat strain

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01290159
Responsible party
Prof. Yoram Epstein (Heller institue, Sheba Medical Center, Sheba Medical Center) — Principal investigator
First posted
Feb 4, 2011
Start date
May 2011
Primary completion
Apr 2013
Completion
Jul 2013
Last update
Dec 19, 2013

Study contacts

Yoram Epstein, PhD
study director · Heller Institute of Medical Research, Sheba Medical Center, Tel Hashomer
Amit Druyan, MD
principal investigator · Heller Institute of Medical Research, Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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