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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:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00808925
First received: December 15, 2008
Last updated: December 14, 2009
Last verified: December 2009
History of Changes
  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:

MedlinePlus related topics: Heat Illness
U.S. FDA Resources

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 Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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
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: Ypram Epstein, PhD; Head Physiology Department at the Heller Institute of Medical Resaearch, Heller Institute of Medical Research, Sheba Medical Center, Tel Hashomer
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 14, 2009
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 May 19, 2013