Metabolic DiseasesMETARUNNCT02275429
Metabolic Disorders in Ultramarathon Runners During and After the Reunion Island Madmen's Diagonal
A study testing Blood test in people with Metabolic Diseases, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Diseases
- What is being tested?
- Blood test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Reunion Island University Hospital
Saint-Denis, Reunion Island, 97410
About this study
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
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.
Read the 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.
- Conditions
- Metabolic Diseases
- Being tested
- Blood test
- 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
- Medical subject headings
- Metabolic Diseases, Iron Metabolism Disorders, Water-Electrolyte Imbalance, Hyperkalemia, Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Runners | Other | 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. Receives: Procedure: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (7)
- Assess Ions and trace metals (Sodium, Potassium, Chloride, Zinc)
Measured: 28 days
- Assess Renal function tests (creatinine, blood urea nitrogen)
Measured: 28 days
- Assess liver function (total protein, cardiac markers (myoglobin, CPK-MB)
Measured: 28 days
- Assess iron and ferritin
Measured: 28 days
- Assess blood disorder (vitamin B12, folic acid or vitamin B9)
Measured: 28 days
- Assess hematology disorder
Measured: 28 days
Fatigue assessment: assessed via a visual analogue scale
Fatigue will be assessed via a visual analogue scale
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme SUDRIAL, MD, Principal investigator, CHU Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275429
- Sponsor's protocol ID
- 2014/CHU/03
- Acronym
- METARUN
- Status last verified
- Jul 2015
- First submitted
- 15 Oct 2014
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02275429
- Acronym / sponsor ID
- METARUN / 2014/CHU/03
- Conditions
- Metabolic Diseases
- Keywords
- Metabolic Diseases, Athletes, Running, Selenium, Zinc, Iron Metabolism Disorders, Water-Electrolyte Imbalance, Hyperkalemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Runners | Other | Procedure: Blood testEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testblood 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 | Procedure or surgery | Runners |
Primary outcome
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.
7 secondary outcomes
- Assess Ions and trace metals (Sodium, Potassium, Chloride, Zinc)
Time frame: 28 days
- Assess Renal function tests (creatinine, blood urea nitrogen)
Time frame: 28 days
- Assess liver function (total protein, cardiac markers (myoglobin, CPK-MB)
Time frame: 28 days
- Assess iron and ferritin
Time frame: 28 days
- Assess blood disorder (vitamin B12, folic acid or vitamin B9)
Time frame: 28 days
- Assess hematology disorder
Time frame: 28 days
Fatigue assessment: assessed via a visual analogue scale
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme SUDRIAL, MD principal investigator
CHU Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Metabolic Diseases, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the selenium levels (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.