Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 15, 2008
December 18, 2013
January 2009
April 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00808925 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Impact of Heat Acclimation on Pro- and Anti- Inflammatory Cytokine Response
The Impact of Heat Acclimation on Pro- and Anti- Inflammatory Cytokine Response

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
"Exposure to Heat"
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
Experimental: research arm
Intervention: Other: exposure to heat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
July 2013
April 2013   (final data collection date for primary outcome measure)

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.
Male
18 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00808925
SHEBA-08-5524-YE-CTIL
No
Prof. Yoram Epstein, Sheba Medical Center
Prof. Yoram Epstein
Medical Corps, Israel Defense Force
Study Director: Daniel S Moran, PhD Institute of Military Physiology, IDF Medical Corps
Sheba Medical Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP