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

University Hospital, Angers69 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Peripheral Artery Disease

Interventions

Capillary blood sampling from the earlobeBIOLOGICAL

Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre hospitalier universitaire

Angers, France

Outcomes

Primary Outcomes

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

Time frame: Half an hour (includes the resting walking and recovery period of exercise)

Secondary Outcomes

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.

Time frame: Half an hour (includes the resting walking and recovery period of exercise)

Data from ClinicalTrials.gov

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