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

NCT01290159 | Completed

• 1 other identifier: SHEBA-10-8150-CM-CTIL
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heat Stroke; Healthy

Keywords

tolerance to heat

Study Arms (3)

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

heat tolerance test (HTT) 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.

Also known as: heat strain

healthy controls; post heat stroke heat intolerant; post heat stroke heat tolerant

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Heller Institute of Medical Research, Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Heat Stroke

Condition Hierarchy (Ancestors)

Heat Stress Disorders; Wounds and Injuries

Study Officials

• Yoram Epstein, PhD

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

  STUDY DIRECTOR

• Amit Druyan, MD

  Heller Institute of Medical Research, Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Heller institue, Sheba Medical Center

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 4, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

IL (1)