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

This study has been terminated.
Sponsor:
Collaborator:
Medical Corps, Israel Defense Force
Information provided by (Responsible Party):
Prof. Yoram Epstein, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00808925
First received: December 15, 2008
Last updated: December 18, 2013
Last verified: December 2013
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 10
Study Start Date: January 2009
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: research arm Other: exposure to heat
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.
Other Name: acclimation to heat

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

Locations
Israel
Heller Institute of Medical Reachearch, Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Prof. Yoram Epstein
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: Prof. Yoram Epstein, Heller institue, Sheba Medical Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00808925     History of Changes
Other Study ID Numbers: SHEBA-08-5524-YE-CTIL
Study First Received: December 15, 2008
Last Updated: December 18, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
acclimation
heat
cytokines
stress
inflammation

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014