BIOlogical Response to Exercise : A Metabolomic Study in Peripheral Artery Disease (BIOR)

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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BIOlogical Response to Exercise : A Metabolomic Study in Peripheral Artery Disease (BIOR)

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Biological: Capillary blood sampling from the earlobe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old Patient able to walk on a treadmill Patient agrees to be involve in the protocol and sign the consent form Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Analysis of changes in metabolomic signature from rest to post exercise
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing exercise oximetry<br>Patients with PAD referred for treadmill testing and exercise oximetry will have a capillary blood sampling from the earlobe | Biological: Capillary blood sampling from the earlobe<br>* Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chances in the metabolomic signature of arterial claudication by capillary blood sampling from the earlobe | Search a significant difference between biological markers before and after the test during a walk on a treadmill | Half an hour (includes the resting walking and recovery period of exercise) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes inthe correlation of observed metabolomic variations and the importance of ischemia evaluated by oximetry | Evaluate the coefficient of correlation between the changes of metabolomic pârameters and the sum of the observed DROPmin values of all studied subjects. | Half an hour (includes the resting walking and recovery period of exercise) |