- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02275429
Metabolic Disorders in Ultramarathon Runners During and After the Reunion Island Madmen's Diagonal (METARUN)
Etude Des Troubles métaboliques Induits Par Une Course à Pied très Longue Distance, " La Diagonale Des Fous " de La Réunion / Metabolic Disorders in Ultramarathon Runners of the Madmen's Diagonal Race on Reunion Island
Study Overview
Detailed Description
Ultramarathons are races involving walking or running longer than the traditional marathon length of 42km and frequently take longer than 12 hours to complete. These races are increasingly frequent and racers attempt to push back the limits of what their body can accomplish. However, these races are not without certain risks.
The Reunion Island Grand Raid (or Madmen's Diagonal) is one such race, crossing the island over 163 km (101 mi) with an altitude gain of 9,643 meters (31,637 ft). Temperatures vary from 0 et 30 degrees Celsius (32-86°F) and the race can take 27 to 67 hours to complete. About 40% of the racers do not cross the finish line. Each year, two or three racers are hospitalized each year in the intensive care unit (ICU) for tubular necrosis and treated with dialysis. Scientific literature shows that racers can present acute rhabdomyolysis, with elevated levels of CPK-MB. Nevertheless, there have been very few studies on the impact of these ultramarathon racers on other biological parameters. As the racers compete and lose about a liter of sweat every hour, they also lose ions and trace metals such as zinc, copper, iron, magnesium, which can have major repercussions during and after the race. These losses are akin to those observed in severe burn victims. In these patients, it has been shown that supplementation in trace elements can decrease mortality and hospitalization time.
Moreover, a major inflammatory response has been observed in racers who compete in ultramarathons. This inflammatory response is similar to that of the systemic inflammatory response syndrome (SIRS). Patients in the ICU who are septic or who present a SIRS also have metabolic diseases, and it has been shown that selenium levels are a prognostic factor of SIRS and supplementation can increase survival rates.
Investigators present the hypothesis that ultramarathon racers can have decreased levels of selenium and other ions and trace metals and that specific supplementation can limit risks and improve recovery. More specifically, investigators suggest that selenium levels will decrease by 25% after the race and remain so at least a week.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Reunion Island
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Saint Denis, Reunion Island, France, 97410
- Reunion Island University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ultramarathon runner in the Madmen's Diagonal on Reunion Island (October 2014 )
- Aged 18 years or older
- Lives on Reunion Island
- Gave informed consent
- Medical certificate allowing the participation in an ultramarathon
Exclusion Criteria:
- Aged less than 18 years Ultramarathon runner in the Bourbon Trail or Mascarenes races (which take place at the same time as the Madmen's Diagonal)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Runners
Each year, about 1,200 runners residing on Reunion Island take the start of the Madmen's Diagonal ultramarathon.
Among those, 500 runners will be selected at random and will receive a letter informing them of the study and requesting their participation.
Those who accept are to contact the study team.
Among those volunteers, 100 runners will be selected randomly and included in the study.
They will undergo a blood test the day before the race starts (day 0, when they retrieve their race number), upon completion of the race, and upon days 7 and 28.
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blood will be drawn the day before the race (day 0), upon completion of the race (between 27 and 67 hours after departure), and on days 7 and 28
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the selenium levels
Time Frame: 28 days
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Blood wil be analyzed prior to the start of the race, upon completion of the race (anywhere between 27 and 67 hours after the start of the race), and upon days 7 and 28.
Blood will be drawn in the same medical laboratory at the Reunion Island University Hospital site of Saint Denis.
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
- Assess Ions and trace metals (Sodium, Potassium, Chloride, Zinc)
Time Frame: 28 days
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28 days
|
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- Assess Renal function tests (creatinine, blood urea nitrogen)
Time Frame: 28 days
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28 days
|
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- Assess liver function (total protein, cardiac markers (myoglobin, CPK-MB)
Time Frame: 28 days
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28 days
|
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- Assess iron and ferritin
Time Frame: 28 days
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28 days
|
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- Assess blood disorder (vitamin B12, folic acid or vitamin B9)
Time Frame: 28 days
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28 days
|
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- Assess hematology disorder
Time Frame: 28 days
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28 days
|
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Fatigue assessment: assessed via a visual analogue scale
Time Frame: 28 days
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Fatigue will be assessed via a visual analogue scale
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28 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Jérôme SUDRIAL, MD, CHU Réunion
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/CHU/03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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