"Exposure to Heat"NCT00808925
The Impact of Heat Acclimation on Pro- and Anti- Inflammatory Cytokine Response
A study testing exposure to heat in people with "Exposure to Heat", run by Prof. Yoram Epstein at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- "Exposure to Heat"
- What is being tested?
- exposure to heat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age:18-25
- medically screened (healthy)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Heller Institute of Medical Reachearch, Sheba Medical Center
Tel HaShomer, 52621
About this study
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.
- Conditions
- "Exposure to Heat"
- Being tested
- exposure to heat
- Keywords
- acclimation, heat, cytokines, stress, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to heatOther
Also called acclimation 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.
| Study group | Role | What they receive |
|---|---|---|
| research arm | Experimental | Not described Receives: Other: exposure to heat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigating the variability in the levels of different cytokine and the kinetics in cytokine levels during the process of acclimation to heat.
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionApr 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for "Exposure to Heat"Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Yoram Epstein
- Sponsor type
- Other government
- Collaborators
- Medical Corps, Israel Defense Force
- Responsible party
- Sponsor-investigator, Prof. Yoram Epstein, Sheba Medical Center
- Investigators
- Daniel S Moran, PhD, Study director, Institute of Military Physiology, IDF Medical Corps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808925
- Sponsor's protocol ID
- SHEBA-08-5524-YE-CTIL
- Status last verified
- Dec 2013
- First submitted
- 15 Dec 2008
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Heat Acclimation on Pro- and Anti- Inflammatory Cytokine Response
- ClinicalTrials.gov ID
- NCT00808925
- Acronym / sponsor ID
- SHEBA-08-5524-YE-CTIL
- Conditions
- "Exposure to Heat"
- Keywords
- acclimation, heat, cytokines, stress, inflammation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Prof. Yoram EpsteinOther government
- Collaborators
- Medical Corps, Israel Defense Force
- Study start
- Jan 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| research arm | Experimental | Other: exposure to heat |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age:18-25
- medically screened (healthy)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exposure to heatAlso: acclimation to heatDressed 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 | research arm |
Primary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel S Moran, PhD study director
Institute of Military Physiology, IDF Medical Corps
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exposure to heat in people with "Exposure to Heat", run by Prof. Yoram Epstein at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.