BIOlogical Response to Exercise : A Metabolomic Study in Peripheral Artery Disease (BIOR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Chances in the metabolomic signature of arterial claudication by capillary blood sampling from the earlobe
研究概览
简要总结
The measurement of the transcutaneous oxygen pressure during walking allows to estimate the importance of ischemia, bilaterally and segment of limb by segment of limb. The determination of the metabolic compounds concentration, with metabolomic approach, is emerging in physiology and exercise.
This pilot study focuses on the feasibility of the metabolomics analysis with micro method , by capillary drawing from earlobe sampling, for patients with peripheral artery disease (PAD)
详细描述
Ankle brachial index is measured at rest for alml subjects. Blood sample (180-360 microliter) will be collected at rest transcutaneous oxygen pressure is measured at the chest, calves and buttocks and results will be expressed as the minimal value of the DROP index (Limb changes minus chest changes) Patients walk on treadmill (2MPH 10% slope) until exertional limb pain. Blood sample (180 microliter) will be collected again, at minute 3 of recovery from walking Correlation of each metobolite increase to the sum of DROP values wil be studied.
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
盲法说明
Metabolomic analysis will be performed blinded to the exercise test results
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Patient able to walk on a treadmill
- •Patient agrees to be involve in the protocol and sign the consent form
排除标准
- •Patient not covered by the French health insurance
- •Patient has a wash-out period for another clinical trial
- •Patient with comorbidity as bleeding disorder or with a anticoagulant therapy
结局指标
主要结局
Chances in the metabolomic signature of arterial claudication by capillary blood sampling from the earlobe
时间窗: Half an hour (includes the resting walking and recovery period of exercise)
Search a significant difference between biological markers before and after the test during a walk on a treadmill
次要结局
- Changes inthe correlation of observed metabolomic variations and the importance of ischemia evaluated by oximetry(Half an hour (includes the resting walking and recovery period of exercise))