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

Metabolic Diseases Clinical Trial

— METARUN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275429
• Other study ID #: 2014/CHU/03
• Status: Completed
• Phase: N/A
• First received: October 15, 2014
• Last updated: July 28, 2015
• Start date: October 2014
• Est. completion date: November 2014

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Metabolic Diseases

Intervention

Procedure:
• Blood test
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

Locations

Country	Name	City	State
France	Reunion Island University Hospital	Saint Denis	Reunion Island

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the selenium levels	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.	28 days	No
Secondary	- Assess Ions and trace metals (Sodium, Potassium, Chloride, Zinc)		28 days	No
Secondary	- Assess Renal function tests (creatinine, blood urea nitrogen)		28 days	No
Secondary	- Assess liver function (total protein, cardiac markers (myoglobin, CPK-MB)		28 days	No
Secondary	- Assess iron and ferritin		28 days	No
Secondary	- Assess blood disorder (vitamin B12, folic acid or vitamin B9)		28 days	No
Secondary	- Assess hematology disorder		28 days	No
Secondary	Fatigue assessment: assessed via a visual analogue scale	Fatigue will be assessed via a visual analogue scale	28 days	No