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

Primary Purpose

Metabolic Diseases

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood test
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Diseases focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Reunion Island University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Runners

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

- Assess Ions and trace metals (Sodium, Potassium, Chloride, Zinc)
- Assess Renal function tests (creatinine, blood urea nitrogen)
- Assess liver function (total protein, cardiac markers (myoglobin, CPK-MB)
- Assess iron and ferritin
- Assess blood disorder (vitamin B12, folic acid or vitamin B9)
- Assess hematology disorder
Fatigue assessment: assessed via a visual analogue scale
Fatigue will be assessed via a visual analogue scale

Full Information

First Posted
October 15, 2014
Last Updated
July 28, 2015
Sponsor
Centre Hospitalier Universitaire de la Réunion
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1. Study Identification

Unique Protocol Identification Number
NCT02275429
Brief Title
Metabolic Disorders in Ultramarathon Runners During and After the Reunion Island Madmen's Diagonal
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Runners
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Blood test
Intervention Description
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 Outcome Measure Information:
Title
Assess the selenium levels
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
- Assess Ions and trace metals (Sodium, Potassium, Chloride, Zinc)
Time Frame
28 days
Title
- Assess Renal function tests (creatinine, blood urea nitrogen)
Time Frame
28 days
Title
- Assess liver function (total protein, cardiac markers (myoglobin, CPK-MB)
Time Frame
28 days
Title
- Assess iron and ferritin
Time Frame
28 days
Title
- Assess blood disorder (vitamin B12, folic acid or vitamin B9)
Time Frame
28 days
Title
- Assess hematology disorder
Time Frame
28 days
Title
Fatigue assessment: assessed via a visual analogue scale
Description
Fatigue will be assessed via a visual analogue scale
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme SUDRIAL, MD
Organizational Affiliation
CHU Réunion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reunion Island University Hospital
City
Saint Denis
State/Province
Reunion Island
ZIP/Postal Code
97410
Country
France

12. IPD Sharing Statement

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

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