The Impact of Heat Acclimation on Pro- and Anti- Inflamma... | NCT00808925

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

NCT00808925

Sponsor

Prof. Yoram Epstein

Status

Terminated

Last Update Posted

Dec 19, 2013Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

"Exposure to Heat"

Interventions

exposure to heat

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Apr 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Dec 15, 2008

First Submission Date that Met QC Criteria

Dec 15, 2008

First Posted Date

Dec 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2013

Last Update Posted Date

Dec 19, 2013Estimated

Name	Class
Medical Corps, Israel Defense Force	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
research arm	Experimental		Other: exposure to heat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exposure to heat	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigating the variability in the levels of different cytokine and the kinetics in cytokine levels during the process of acclimation to heat.		12 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel S Moran, PhD	Institute of Military Physiology, IDF Medical Corps	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heller Institute of Medical Reachearch, Sheba Medical Center		Tel Litwinsky		52621	Israel

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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