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

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Biological: Capillary blood sampling from the earlobe

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Centre Hospitalier Universitaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients undergoing exercise oximetry; 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; Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Pierre ABRAHAM, MD, Ph.D, University Hospital in Angers

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): March 18, 2019
• Study Completion (Actual): March 18, 2019

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 2017-A01147-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No