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Sickle Cell Trait and Exercise, Effect of Hot Environment (TDex)

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ClinicalTrials.gov Identifier: NCT04028791
Recruitment Status : Completed
First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Sophie Antoine-Jonville, University of the French West Indies and French Guiana

Brief Summary:

The heterozygous form of sickle cell disease is clinically asymptomatic. Nevertheless, it was observed that, the sickle cell trait is associated with serious medical complications especially during intense physical efforts. Moreover, the exposure to a hot environment (tropical climate) is suspected to be a determining factor in the occurrence of these medical complications.

However, the relationship between sickle cell trait and death during effort is not well established. Furthermore, the cascade of events that usually cause sickle cell crisis such as red blood cells sickling and rhabdomyolysis and which affect microcirculation are not known.

Our main objective in this study is to verify whether young healthy active men with sickle cell trait have reactive hyperemia to their hemoglobinemic condition during exercise; to identify the contribution of hot environment on these possible disturbances; and to determine underlying mechanisms.

In addition, disturbances in the regulation of glucose metabolism in healthy subjects under hot environment have been reported, marked by a significant increase in postprandial blood glucose. Therefore, this project is also intended to assess the contribution of the disturbance of glycoregulation during exercise under hot environment in active sickle cell trait carriers. The imbalance of pro and anti oxidant agents, the adhesion and inflammation markers will also be evaluated.

Results of this study will allow a better understanding of physio-pathological mechanisms leading to vascular accidents during exercise under tropical climate in young healthy sickle cell trait carriers; and to identify physical activity programs and nutritional interventions adapted to patients with sickle cell disease under hot environment.

Condition or disease Intervention/treatment Phase
Sickle Cell Trait Environmental Exposure Adverse Effect Other: Exercise on ergocycle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

All participants in each group (AA, AS) will carry out the following 3 sessions:

  1. Exercise performed in hot environment (33 °C) with recovery in the same environment
  2. Exercise and recovery performed in a control (thermoneutral) environment (22 °C),
  3. Exercise performed in a hot environment (33 °C) with recovery in a thermoneutral, environment (22 °C).
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Metabolic and Vascular Response to Exercise in Sickle Cell Trait Carriers: Effect of Hot Environment
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Arm Intervention/treatment
Experimental: AS and AA
Participants will be submitted to 45 minutes of exercise on ergocycle.
Other: Exercise on ergocycle
The exercise includes 15 minutes of warm up, then participants will be asked to pedal as fast as possible for 6 seconds. The test of 6 seconds will be repeated twice or more with recovery each time

Primary Outcome Measures :
  1. Microvascular function [ Time Frame: 2 hours ]
    Reactive hyperemia index (arbitrary units) will be assessed at rest, during exercise and during recovery in hot and thermoneutral environment

Secondary Outcome Measures :
  1. Oxidative stress [ Time Frame: 3 months ]
    Glutathione ratio GSSH/GSSG

  2. Inflammation [ Time Frame: 3 months ]
    Myeloperoxidase (MPO)

  3. Adhesion molecules [ Time Frame: 3 mois ]

  4. Hemorheology [ Time Frame: 24 hours ]

  5. Rhamdomyolysis [ Time Frame: 3 months ]
    Creatine kinase

  6. Oxydative stress marker [ Time Frame: 3 months ]
    superoxide dismutase (SOD)

Other Outcome Measures:
  1. Glucose metabolism [ Time Frame: 3 months ]

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • BMI between 19 and 25kg/m2,
  • Be living in the Caribbean for at least 6 months health
  • Be physically active (≥ 1350 METs/week)
  • No history of heat stroke during exercise
  • No taking any medications
  • Not regularly consuming alcohol
  • Have the ability and willingness to issue consent written, free and enlightened

Exclusion Criteria:

  • Have any other hemoglobinemic status than AA or AS.
  • Weight gain or loss of more than 2 kg in the last 6 month.
  • Food allergy to any of ingredients coming into the composition of test meals or that may result from a cross-contamination during manufacture: eggs and eggs products, gluten, milk and milk-based products (including lactose), soybean and soy products, fruit hulls (almonds, hazelnuts, walnuts, cashew nuts, pecan, macadamia, Brazil, Queensland, pistachios) and products made of these fruits.
  • Monitoring a particular diet
  • Any chronic metabolic pathology, cardiovascular, neurovascular, renal, respiratory, neuromuscular, musculoskeletal or articular known
  • Any disorder of the ear (infections, tumors, perforated eardrums, polyps)
  • Any infectious disease or inflammatory and infectious condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028791

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ACTES laboratory
Pointe-à-Pitre, Guadeloupe, 97157
Sponsors and Collaborators
University of the French West Indies and French Guiana
Institut National de la Santé Et de la Recherche Médicale, France
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Principal Investigator: Stéphane Henri, Dr Laboratoire ACTES, EA 3596 UFR STAPS, University of the French West Indies and French Guiana
Study Director: Olivier Hue, PhD Laboratoire ACTES, EA 3596 UFR STAPS, University of the French West Indies and French Guiana
Principal Investigator: Mona Hedreville, Dr Unités Urgences cardiologiques CHU, Pointe-à-Pitre/Abymes 97159

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Responsible Party: Sophie Antoine-Jonville, Director, University of the French West Indies and French Guiana
ClinicalTrials.gov Identifier: NCT04028791    
Other Study ID Numbers: 2017-A02226-47
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All autors have to discuss together before to decide

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sophie Antoine-Jonville, University of the French West Indies and French Guiana:
Exercise, sickling, rhamdomyolysis, oxidative stress
Additional relevant MeSH terms:
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Sickle Cell Trait
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn