Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03305198
Acronym
BIOR
Enrollment
69
Registered
2017-10-09
Start date
2017-10-01
Completion date
2019-03-18
Last updated
2019-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

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.

Interventions

BIOLOGICALCapillary blood sampling from the earlobe

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

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

Metabolomic analysis will be performed blinded to the exercise test results

Intervention model description

Analysis of changes in metabolomic signature from rest to post exercise

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Chances in the metabolomic signature of arterial claudication by capillary blood sampling from the earlobeHalf 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

MeasureTime frameDescription
Changes inthe correlation of observed metabolomic variations and the importance of ischemia evaluated by oximetryHalf 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026