Effects of Endogenous Iron Status and Intravenous Iron on Human Skeletal Muscle Metabolism at Rest and During Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Phosphocreatine depletion during small muscle mass exercise
研究概览
简要总结
Iron deficiency is common in cardiorespiratory diseases and appears to contribute to a worse outcome. This human physiology study will examine the extent to which human skeletal muscle metabolism and exercise physiology are impaired by iron deficiency.
详细描述
This is a prospective double-blind randomised controlled study of the effect of endogenous iron status on skeletal muscle metabolism and exercise physiology. 32 healthy volunteers will take part, half of whom will be iron-deficient. The study involves a screening visit and two half-day visits during which assessments are performed. 50% of each group will be randomised to receive iron-repletion with ferric carboxymaltose at the end of the first experimental visit before returning to repeat identical assessments around one week later. This approach will make it possible to explore whether baseline differences in skeletal muscle metabolism are explained by differences in iron status per se, whilst controlling for any learning effect during participation in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give informed consent for participation in the study
- •Men and women aged 18 years or older and generally in good health
- •For iron-deficient volunteers: ferritin ≤ 15 microg/L and transferrin saturation < 16%
- •For iron-replete volunteers: ferritin ≥ 20 microg/L and transferrin saturation ≥ 20%
排除标准
- •Haemoglobin < 8.0 g/dL
- •Haemoglobinopathy
- •Iron overload, defined as ferritin > 300 microg/L
- •Hypoxaemia (SpO2 < 94%) or significant co-morbidity that may affect haematinics, metabolic or ventilatory responses
- •Iron supplementation or blood transfusion within the previous 6 weeks
- •Pregnancy or breast feeding
- •Inability to exercise isolated calf muscle using a pedal or on a bicycle ergometer
- •Contraindication to magnetic resonance spectroscopy exposure such as metallic implant
- •Contraindication to receiving intravenous ferric carboxymaltose
研究组 & 干预措施
Iron-deficient, given placebo
Iron-deficient participants given an infusion of sodium chloride at conclusion of baseline experimental visit
干预措施: Sodium chloride (placebo) (Drug)
Iron-deficient, given iron
Iron-deficient participants given an infusion of ferric carboxymaltose at conclusion of baseline experimental visit
干预措施: Ferric carboxymaltose (Drug)
Iron-replete, given placebo
Iron-replete participants given an infusion of sodium chloride at conclusion of baseline experimental visit
干预措施: Sodium chloride (placebo) (Drug)
Iron-replete, given iron
Iron-deficient participants given an infusion of ferric carboxymaltose at conclusion of baseline experimental visit
干预措施: Ferric carboxymaltose (Drug)
结局指标
主要结局
Phosphocreatine depletion during small muscle mass exercise
时间窗: 36 minute long graded exercise test; performed at baseline and follow-up visits (approximately a week apart)
Degree of phosphocreatine depletion during graded exercise of calf muscle assessed using magnetic resonance spectroscopy
次要结局
- Cardiopulmonary exercise test performance(Hour long graded exercise test; performed at baseline and follow-up visits (approximately a week apart))
- Participant reported symptoms(At study screening visit compared to four weeks following infusion of iron or placebo)
- Muscle biopsy findings(Immediately before and immediately after hour long cardiopulmonary exercise test, performed at baseline and follow-up visits (approximately a week apart))