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

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)

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier universitaire

Angers, 49933, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capillary blood sampling from the earlobe

Biological

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

Primary outcomes

Chances in the metabolomic signature of arterial claudication by capillary blood sampling from the earlobe

Time frame: 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

Secondary outcomes

Changes inthe correlation of observed metabolomic variations and the importance of ischemia evaluated by oximetry

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

Evaluate the coefficient of correlation between the changes of metabolomic pârameters and the sum of the observed DROPmin values of all studied subjects.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: BIOR

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Oct 9, 2017
Registry last updated: Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed