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Completed

NCT Number: NCT02275429

Metabolic Disorders in Ultramarathon Runners During and After the Reunion Island Madmen's Diagonal

Acute consequences of ultramarathon running are still unknown as very little research has been done on the matter. The investigators will assess the consequences on the metabolism of runners in the ultramarathon Madmen's Diagonal on Reunion Island. Data from the literature suggest that runners undergo loss of zinc, copper, iron, magnesium not unlike the loss of metabolites in systemic inflammatory response syndrome. The purpose of this study is to assess the metabolic disorders (selenium, zinc, vitamins B9 and B12) in ultramarathon runners, during and up to 28 days after the Madmen's Diagonal which takes place on Reunion Island every year in October.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reunion Island University Hospital

Saint-Denis, Reunion Island, 97410, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood test

Procedure

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

Primary outcomes

  1. Assess the selenium levels

    Time frame: 28 days

    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.

Secondary outcomes

  1. - Assess Ions and trace metals (Sodium, Potassium, Chloride, Zinc)

    Time frame: 28 days

  2. - Assess Renal function tests (creatinine, blood urea nitrogen)

    Time frame: 28 days

  3. - Assess liver function (total protein, cardiac markers (myoglobin, CPK-MB)

    Time frame: 28 days

  4. - Assess iron and ferritin

    Time frame: 28 days

  5. - Assess blood disorder (vitamin B12, folic acid or vitamin B9)

    Time frame: 28 days

  6. - Assess hematology disorder

    Time frame: 28 days

  7. Fatigue assessment: assessed via a visual analogue scale

    Time frame: 28 days

    Fatigue will be assessed via a visual analogue scale

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study title

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

Acronym: METARUN

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 27, 2014
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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