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

Peripheral Artery Disease Clinical Trial

— BIOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305198
• Other study ID #: 2017-A01147-46
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: March 18, 2019

Study information

• Verified date: March 2019
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: March 18, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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

Locations

Country	Name	City	State
France	Centre hospitalier universitaire	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)