Sickle Cell Trait and Exercise, Effect of Hot Environment

NCT04028791 | Completed DMC

• 1 other identifier: 2017-A02226-47
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Trait; Environmental Exposure; Adverse Effect

Keywords

Exercise, sickling, rhamdomyolysis, oxidative stress

Outcome Measures

Primary Outcomes (1)

• Microvascular function

  Reactive hyperemia index (arbitrary units) will be assessed at rest, during exercise and during recovery in hot and thermoneutral environment

  2 hours

Secondary Outcomes (6)

• Oxidative stress

  3 months

• Inflammation

  3 months

• Adhesion molecules

  3 mois

• Hemorheology

  24 hours

• Rhamdomyolysis

  3 months

Other Outcomes (1)

• Glucose metabolism

  3 months

Study Arms (1)

AS and AA

EXPERIMENTAL

Participants will be submitted to 45 minutes of exercise on ergocycle.

Other: Exercise on ergocycle

Interventions

Exercise on ergocycle OTHER

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

AS and AA

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the French West Indies and French Guiana: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

ACTES laboratory

Pointe-à-Pitre, 97157, Guadeloupe

Location

Related Publications (11)

• Bergeron MF, Cannon JG, Hall EL, Kutlar A. Erythrocyte sickling during exercise and thermal stress. Clin J Sport Med. 2004 Nov;14(6):354-6. doi: 10.1097/00042752-200411000-00005.

  PMID: 15523207 BACKGROUND

• Connes P, Sara F, Hardy-Dessources MD, Marlin L, Etienne F, Larifla L, Saint-Martin C, Hue O. Effects of short supramaximal exercise on hemorheology in sickle cell trait carriers. Eur J Appl Physiol. 2006 May;97(2):143-50. doi: 10.1007/s00421-006-0155-3. Epub 2006 Feb 28.

  PMID: 16506056 BACKGROUND

• Faure C, Charlot K, Henri S, Hardy-Dessources MD, Hue O, Antoine-Jonville S. Impaired glucose tolerance after brief heat exposure: a randomized crossover study in healthy young men. Clin Sci (Lond). 2016 Jun 1;130(12):1017-25. doi: 10.1042/CS20150461. Epub 2016 Mar 15.

  PMID: 26980346 BACKGROUND

• Kark JA, Posey DM, Schumacher HR, Ruehle CJ. Sickle-cell trait as a risk factor for sudden death in physical training. N Engl J Med. 1987 Sep 24;317(13):781-7. doi: 10.1056/NEJM198709243171301.

  PMID: 3627196 BACKGROUND

• Kerle KK, Nishimura KD. Exertional collapse and sudden death associated with sickle cell trait. Mil Med. 1996 Dec;161(12):766-7.

  PMID: 8990839 BACKGROUND

• Kerle KK, Runkle GP. Sickle cell trait and sudden death in athletes. JAMA. 1996 Nov 13;276(18):1472. No abstract available.

  PMID: 8903257 BACKGROUND

• Le Gallais D, Bile A, Mercier J, Paschel M, Tonellot JL, Dauverchain J. Exercise-induced death in sickle cell trait: role of aging, training, and deconditioning. Med Sci Sports Exerc. 1996 May;28(5):541-4. doi: 10.1097/00005768-199605000-00001.

  PMID: 9148081 BACKGROUND

• Monchanin G, Connes P, Wouassi D, Francina A, Djoda B, Banga PE, Owona FX, Thiriet P, Massarelli R, Martin C. Hemorheology, sickle cell trait, and alpha-thalassemia in athletes: effects of exercise. Med Sci Sports Exerc. 2005 Jul;37(7):1086-92. doi: 10.1249/01.mss.0000170128.78432.96.

  PMID: 16015123 BACKGROUND

• O'Connor FG, Bergeron MF, Cantrell J, Connes P, Harmon KG, Ivy E, Kark J, Klossner D, Lisman P, Meyers BK, O'Brien K, Ohene-Frempong K, Thompson AA, Whitehead J, Deuster PA. ACSM and CHAMP summit on sickle cell trait: mitigating risks for warfighters and athletes. Med Sci Sports Exerc. 2012 Nov;44(11):2045-56. doi: 10.1249/MSS.0b013e31826851c2.

  PMID: 22811029 BACKGROUND

• Quattrone RD, Eichner ER, Beutler A, Adams WB, O'Connor FG. Exercise collapse associated with sickle cell trait (ECAST): case report and literature review. Curr Sports Med Rep. 2015 Mar-Apr;14(2):110-6. doi: 10.1249/JSR.0000000000000137.

  PMID: 25757006 BACKGROUND

• Wirthwein DP, Spotswood SD, Barnard JJ, Prahlow JA. Death due to microvascular occlusion in sickle-cell trait following physical exertion. J Forensic Sci. 2001 Mar;46(2):399-401.

  PMID: 11305451 BACKGROUND

MeSH Terms

Conditions

Sickle Cell Trait; Motor Activity

Condition Hierarchy (Ancestors)

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Officials

• Stéphane Henri, Dr

  Laboratoire ACTES, EA 3596 UFR STAPS, University of the French West Indies and French Guiana

  PRINCIPAL INVESTIGATOR

• Olivier Hue, PhD

  Laboratoire ACTES, EA 3596 UFR STAPS, University of the French West Indies and French Guiana

  STUDY DIRECTOR

• Mona Hedreville, Dr

  Unités Urgences cardiologiques CHU, Pointe-à-Pitre/Abymes 97159

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 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).

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 23, 2019
• Study Start: September 25, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

GU (1)