Clinical trial NCT02275429: Metabolic Disorders in Ultramarathon Runners During and After the Reunion Island Madmen's Diagonal
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Diseases
Keywords: Metabolic Diseases
Athletes
Running
Selenium
Zinc
Iron Metabolism Disorders
Water-Electrolyte Imbalance
Hyperkalemia
Hypernatremia
Selenium levels before and after the race
Levels of other electrolytes and markers
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Assess the selenium levels
timeFrame: 28 days
Secondary outcomes:
measure: - Assess Ions and trace metals (Sodium, Potassium, Chloride, Zinc)
timeFrame: 28 days
measure: - Assess Renal function tests (creatinine, blood urea nitrogen)
timeFrame: 28 days
measure: - Assess liver function (total protein, cardiac markers (myoglobin, CPK-MB)
timeFrame: 28 days
measure: - Assess iron and ferritin
timeFrame: 28 days
measure: - Assess blood disorder (vitamin B12, folic acid or vitamin B9)
timeFrame: 28 days
measure: - Assess hematology disorder
timeFrame: 28 days
measure: Fatigue assessment: assessed via a visual analogue scale
timeFrame: 28 days
Other outcomes:
Locations:
city: Saint Denis
country: France
facility: Reunion Island University Hospital
state: Reunion Island
Study officials:
affiliation: CHU Réunion
name: Jérôme SUDRIAL, MD
role: PRINCIPAL_INVESTIGATOR
References: