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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Yoram Epstein, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01290159
First received: February 3, 2011
Last updated: December 18, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by 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

Ages Eligible for Study:   18 Years to 28 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 3, 2011
Last Updated: December 18, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
tolerance to heat

Additional relevant MeSH terms:
Heat Stroke
Stroke
Heat Stress Disorders
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014