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

Heat Stroke Clinical Trial

— EXPLO-CCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593316
• Other study ID #: 2019PBMD03
• Secondary ID: 2020-A01967-32
• Status: Recruiting
• Start date: November 2, 2020
• Est. completion date: November 2024

Study information

• Verified date: March 2021
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Arnaud-Xavier JOUVION, MD
• Phone: 491617679
• Email: arnaud-xavier.jouvion[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Heat Stroke

Intervention

Other:
• Saliva collection
A saliva sample will be collected before physical exercise.

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

Other:
• Ingestible core temperature capsule intake
The participant will ingest a capsule before physical exercise in order to continuously monitor core temperature during physical exercise.
• Physical exercise
The participant will perform a walk/run test.
• Heart rate monitoring
Heart rate will be monitored during physical exercise thanks to a chest belt.
• Core temperature monitoring
Heart rate will be monitored during physical exercise thanks to an ingestible core temperature capsule.

Locations

Country	Name	City	State
France	Institut de Recherche Biomédicale des Armées	Brétigny-sur-Orge
France	Hôpital d'Instruction des Armées Laveran	Marseille
France	Ecole du Val-de-Grâce	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of the frequency of CYP24A1 gene polymorphisms between the heatstroke group and the control group	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.	At enrollment (day 1)
Primary	Difference of the frequency of DRD2 gene polymorphisms between the heatstroke group and the control group	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.	At enrollment (day 1)
Primary	Difference of the frequency of BDNF gene polymorphisms between the heatstroke group and the control group	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.	At enrollment (day 1)
Primary	Difference of the frequency of COMT gene polymorphisms between the heatstroke group and the control group	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.	At enrollment (day 1)
Primary	Difference of the frequency of FAAH gene polymorphisms between the heatstroke group and the control group	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.	At enrollment (day 1)
Primary	Difference of the frequency of TPH2 gene polymorphisms between the heatstroke group and the control group	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.	At enrollment (day 1)
Primary	Difference of the frequency of GRIN2B gene polymorphisms between the heatstroke group and the control group	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.	At enrollment (day 1)
Primary	Difference of the frequency of PER3 gene polymorphisms between the heatstroke group and the control group	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.	At enrollment (day 1)
Primary	Difference of the frequency of TNF-a gene polymorphisms between the heatstroke group and the control group	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.	At enrollment (day 1)
Primary	Difference of the frequency of IL-6 gene polymorphisms between the heatstroke group and the control group	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.	At enrollment (day 1)
Primary	Difference of the frequency of IL1B gene polymorphisms between the heatstroke group and the control group	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.	At enrollment (day 1)
Primary	Difference of the frequency of HSPA1B gene polymorphisms between the heatstroke group and the control group	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.	At enrollment (day 1)
Primary	Difference of the frequency of TLR4 gene polymorphisms between the heatstroke group and the control group	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.	At enrollment (day 1)