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

Not Applicable

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Biological: Capillary blood sampling from the earlobe

• Registration Number: NCT03305198
• Lead Sponsor: University Hospital, Angers

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-09-28
• Study Start: 2017-10-01
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-09
• Status Verified: 2019-03
• Primary Completion: 2019-03-18
• Study Completion: 2019-03-18
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing exercise oximetry	Capillary blood sampling from the earlobe	Patients with PAD referred for treadmill testing and exercise oximetry will have a capillary blood sampling from the earlobe

Primary Outcome Measures

Name	Time	Method
Chances in the metabolomic signature of arterial claudication by capillary blood sampling from the earlobe	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 Outcome Measures

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

Trial Locations

Locations (1)

Centre hospitalier universitaire; 🇫🇷 Angers, France