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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01290159
First Posted: February 4, 2011
Last Update Posted: December 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Yoram Epstein, Sheba Medical Center
  Purpose
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.

Condition Intervention
Heat Stroke Healthy Other: heat tolerance test (HTT)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preliminary Study of Identifying the Tolerance to Heat by a Novel Biomarker of Oxidative Stress

Further study details as provided by Prof. Yoram Epstein, Sheba Medical Center:

Enrollment: 10
Study Start Date: May 2011
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: heat strain
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 Name: heat strain

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   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
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290159


Locations
Israel
Heller Institute of Medical Research, Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
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
  More Information

Responsible Party: Prof. Yoram Epstein, Heller institue, Sheba Medical Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01290159     History of Changes
Other Study ID Numbers: SHEBA-10-8150-CM-CTIL
First Submitted: February 3, 2011
First Posted: February 4, 2011
Last Update Posted: December 19, 2013
Last Verified: December 2013

Keywords provided by Prof. Yoram Epstein, Sheba Medical Center:
tolerance to heat

Additional relevant MeSH terms:
Heat Stroke
Heat Stress Disorders
Wounds and Injuries