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

Exposure to Heat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00808925
• Other study ID #: SHEBA-08-5524-YE-CTIL
• Status: Terminated
• Phase: N/A
• First received: December 15, 2008
• Last updated: December 18, 2013
• Start date: January 2009
• Est. completion date: July 2013

Study information

• Verified date: December 2013
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Exposure to Heat

Intervention

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.

Locations

Country	Name	City	State
Israel	Heller Institute of Medical Reachearch, Sheba Medical Center	Tel Hashomer

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Yoram Epstein	Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigating the variability in the levels of different cytokine and the kinetics in cytokine levels during the process of acclimation to heat.		12 days	No