The Effects of Post-Conditioning and Administration of Vitamin C on Intramuscular High Energy Phosphate Levels
试验速览
- 阶段
- 不适用
- 试验地点
- 1
研究概览
简要总结
Ischemic injury to muscular tissue is common in cardiovascular medicine. The most effective treatment to avoid ischemic damage is the rapid re-establishment of reperfusion. However, reperfusion itself can result in additional damage to ischemic tissue. This phenomenon is called ischemia - reperfusion (IR) injury and is caused by different pathologic mechanisms.
Therapies are required which can be administered after the onset of an ischemic event to protect the tissue against IR injury. Therefore, a promising strategy to reduce IR injury is post-conditioning.
Likewise, pharmacological therapies administered after the onset of reperfusion might prevent tissue injury. We have recently shown that high concentrations of exogenous vitamin C abrogate experimental IR injury of the forearm vasculature in patients with peripheral artery disease and in healthy subjects.
Study hypothesis
We hypothesize that the administration of mechanical post-conditioning or of high-dose vitamin C may protect skeletal muscle against IR injury. This shall be studied employing MR spectroscopy of the leg, which is an established model to assess muscle aerobic energy metabolism.
Design
Three periods, three way cross over study in 10 volunteers. One screening visit, three one-day study days with two washout periods of >3 days in between are scheduled for each participant. The order of experimental days will be randomized. After the last treatment a final follow-up examination will be performed within one week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged between 18 and 45 years
- •Nonsmoker for more than 3 months
- •Body mass index between 18 and 25 kg/m2
- •Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
排除标准
- •Any of the following will exclude a subject from the study:
- •Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- •Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
- •Treatment in the previous 3 weeks with any drug including over-the-counter drugs.
- •Symptoms of a clinically relevant illness in the 2 weeks before the first study day
- •History or presence of gastrointestinal, liver of kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of the study drug
- •Blood donation during the previous 3 weeks
- •History of hypersensitivity to parenteral vitamin C.
- •Glucose-6-phosphate dehydrogenase deficiency
- •Thalassemia, haemochromatosis
- •History of urolithiasis
- •Any metallic or paramagnetic device not removable
- •Claustrophobia
- •Regular use of supplementary oral Vitamin C or Vitamin C containing substances
研究组 & 干预措施
1
No intervention after IR injury
干预措施: no intervention (Other)
2
Postconditioning
干预措施: Postconditioning (Procedure)
3
Vit. C
干预措施: Vit C (Drug)
