The Impact of Heat Acclimation on Pro- and Anti- Inflammatory Cytokine Response

This study is not yet open for participant recruitment.

Verified by Sheba Medical Center, December 2008

First Received: December 15, 2008 No Changes Posted

Sponsors and Collaborators:	Sheba Medical Center Medical Corps, Israel Defense Force
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00808925

Purpose

There is growing evidence to conclude that part of the cascade leading to heatstroke is related to an inflammatory reaction triggered by the heat stress.

The reduced ability to sustain heat stress - "heat intolerance" is also attributed to over-expression of inflammatory cytokines. Acclimation to heat improves human sustainability to heat and is a leading protective factor against heat stroke. The investigators hypothesize that the lower stress encountered during the process of acclimation to heat will be reflected by an over-ride in the expression of anti-inflammatory over the pro-inflammatory cytokines. This, in turn will attenuate the pathological cascade leading to heat stroke.

Condition	Intervention
"Exposure to Heat"	Other: exposure to heat

MedlinePlus related topics: Heat Illness Heel Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Single Blind (Investigator), Single Group Assignment
Official Title:	The Impact of Heat Acclimation on Pro- and Anti- Inflammatory Cytokine Response

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

Investigating the variability in the levels of different cytokine and the kinetics in cytokine levels during the process of acclimation to heat. [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Dressed in shorts and tennis shoes the subjects will be exposed to exercise-heat stress for 12 consecutive days (excluding Saturday). Daily exposure will last 120 min, under the controlled environmental conditions of 40oC and 40% relative humidity. The exercise will consist of walking on a treadmill at a pace of 5km/h and 2% incline.

Eligibility

Ages Eligible for Study:	18 Years to 25 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

age:18-25
medically screened (healthy)

Exclusion Criteria:

BMI over 22 kg/m2
systolic blood pressure over 120 mmHg
any febrile illness during the last week preceding the study
any skin disease
diabetes
any heart conditions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808925

Contacts

Contact: Tomer Erlich, MD	+972-3-5303564	Tomer.erlich@gmail.com
Contact: Yoram Epstein, PhD	+972-3-5303564	yoram.epstein@sheba.health.gov.il

Locations

Israel
Heller Institute of Medical Reachearch, Sheba Medical Center
Tel Hashomer, Israel, 52621

Sponsors and Collaborators

Sheba Medical Center

Medical Corps, Israel Defense Force

Investigators

Study Director:

Daniel S Moran, PhD

Institute of Military Physiology, IDF Medical Corps

More Information

No publications provided

Responsible Party:	Heller Institute of Medical Research, Sheba Medical Center, Tel Hashomer ( Ypram Epstein, PhD; Head Physiology Department at the Heller Institute of Medical Resaearch )
Study ID Numbers:	SHEBA-08-5524-YE-CTIL
Study First Received:	December 15, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00808925 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

acclimation
heat
cytokines
stress
inflammation

Study placed in the following topic categories:

Stress
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009