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临床试验/NCT02275429
NCT02275429已完成不适用

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

Centre Hospitalier Universitaire de la Réunion2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
2
主要终点
Assess the selenium levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Assess the selenium levels

时间窗: 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.

次要结局

  • - Assess liver function (total protein, cardiac markers (myoglobin, CPK-MB)(28 days)
  • - Assess iron and ferritin(28 days)
  • - Assess Ions and trace metals (Sodium, Potassium, Chloride, Zinc)(28 days)
  • Fatigue assessment: assessed via a visual analogue scale(28 days)
  • - Assess hematology disorder(28 days)
  • - Assess blood disorder (vitamin B12, folic acid or vitamin B9)(28 days)
  • - Assess Renal function tests (creatinine, blood urea nitrogen)(28 days)

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (2)

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