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Study of Risk Factors for the Occurrence and Severity of Exertional Heatstroke in the Military Environment

Study of Risk Factors for the Occurrence and Severity of Exertional Heatstroke in the Military Environment

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04593316
Acronym
EXPLO-CCE
Enrollment
300
Registered
2020-10-20
Start date
2020-11-02
Completion date
2024-11-30
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heat Stroke

Brief summary

Although the circumstances of onset and management of exertional heatstroke have been identified for several years, its pathophysiology remains imperfectly understood. Exertional heatstroke is the result of both extrinsic (i.e. environmental) and intrinsic (i.e. individual) contributing factors. Extrinsic factors are well known (high ambient temperature and hygrometry, poorly breathable clothing, intense and prolonged physical effort) but some of them may be observed in milder conditions. In the French Armed Forces, 25% of the exertional heatstrokes that have been reported between 2005 and 2011 occurred below 17°C. Intrinsic factors, on the other hand, are numerous and less consensual, partly because of the imperfect knowledge of exertional heatstroke physiopathology. Potential factors include a thermoregulatory defect (inability to maintain a temperature plateau during an effort) and several genetic mutations may also contribute to explain a propensity to present an exertional heatstroke. While exertional heatstroke is clearly not a monogenic pathology, the association of several polymorphisms could contribute to this vulnerability. Among the genes that have been explored, mutations in ryanodine receptor type 1 (RyR 1), calsequestrin-1 or angiotensin-1 converting enzyme (ACE) appear to be potential candidates. However, it is very likely that other polymorphisms may be involved, such as: genes involved in sports performance and exercise rhabdomyolysis, in the inflammatory cascade, permeability of the digestive epithelial barrier, adenosine receptors and susceptibility to anxiety. Finally, motivation is a mixed factor often claimed to be involved in exertional heatstroke but has never been quantified and needs to be objectified. To date, none of these hypotheses has been clearly assessed by comparing patients who experienced exertional heatstroke to healthy subjects.

Interventions

OTHERSaliva collection

A saliva sample will be collected before physical exercise.

BEHAVIORALQuestionnaires

The participant will fill in questionnaires relative to his heath status and psychological and motivational resource questionnaires before physical exercise.

OTHERIngestible core temperature capsule intake

The participant will ingest a capsule before physical exercise in order to continuously monitor core temperature during physical exercise.

OTHERPhysical exercise

The participant will perform a walk/run test.

Heart rate will be monitored during physical exercise thanks to a chest belt.

Heart rate will be monitored during physical exercise thanks to an ingestible core temperature capsule.

Sponsors

Direction Centrale du Service de Santé des Armées
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Active military * Between 18 and 45 years old * Ability to the walk/run test

Exclusion criteria

* Ongoing drug treatment (for the control group only), * BMI greater than or equal to 30, * Contraindication to the ingestion of a core temperature capsule

Design outcomes

Primary

MeasureTime frameDescription
Difference of the frequency of CYP24A1 gene polymorphisms between the heatstroke group and the control groupAt enrollment (day 1)The frequency of CYP24A1 gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
Difference of the frequency of DRD2 gene polymorphisms between the heatstroke group and the control groupAt enrollment (day 1)The frequency of DRD2 gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
Difference of the frequency of BDNF gene polymorphisms between the heatstroke group and the control groupAt enrollment (day 1)The frequency of BDNF gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
Difference of the frequency of COMT gene polymorphisms between the heatstroke group and the control groupAt enrollment (day 1)The frequency of COMT gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
Difference of the frequency of FAAH gene polymorphisms between the heatstroke group and the control groupAt enrollment (day 1)The frequency of FAAH gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
Difference of the frequency of TPH2 gene polymorphisms between the heatstroke group and the control groupAt enrollment (day 1)The frequency of TPH2 gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
Difference of the frequency of GRIN2B gene polymorphisms between the heatstroke group and the control groupAt enrollment (day 1)The frequency of GRIN2B gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
Difference of the frequency of PER3 gene polymorphisms between the heatstroke group and the control groupAt enrollment (day 1)The frequency of PER3 gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
Difference of the frequency of TNF-a gene polymorphisms between the heatstroke group and the control groupAt enrollment (day 1)The frequency of TNF-a gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
Difference of the frequency of IL-6 gene polymorphisms between the heatstroke group and the control groupAt enrollment (day 1)The frequency of IL-6 gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
Difference of the frequency of IL1B gene polymorphisms between the heatstroke group and the control groupAt enrollment (day 1)The frequency of IL1B gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
Difference of the frequency of HSPA1B gene polymorphisms between the heatstroke group and the control groupAt enrollment (day 1)The frequency of HSPA1B gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
Difference of the frequency of TLR4 gene polymorphisms between the heatstroke group and the control groupAt enrollment (day 1)The frequency of TLR4 gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.

Countries

France

Contacts

Primary ContactArnaud-Xavier JOUVION, MD
arnaud-xavier.jouvion@intradef.gouv.fr491617679
Backup ContactKeyne CHARLOT
keyne.charlot@intradef.gouv.fr178651303

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026