Back to resultsBIOlogical Response to Exercise : A Metabolomic Study in Peripheral Artery Disease (BIOR) (BIOR)
Primary Purpose
Peripheral Artery Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Capillary blood sampling from the earlobe
Sponsored by
About this trial
This is an interventional basic science trial for Peripheral Artery Disease
Eligibility Criteria
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
Sites / Locations
- Centre hospitalier universitaire
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients undergoing exercise oximetry
Arm Description
Patients with PAD referred for treadmill testing and exercise oximetry will have a capillary blood sampling from the earlobe
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03305198
First Posted
September 28, 2017
Last Updated
March 20, 2019
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT03305198
Brief Title
BIOlogical Response to Exercise : A Metabolomic Study in Peripheral Artery Disease (BIOR)
Acronym
BIOR
Official Title
BIOlogical Response to Exercise : A Metabolomic Study in Peripheral Artery Disease (BIOR)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
March 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Analysis of changes in metabolomic signature from rest to post exercise
Masking
None (Open Label)
Masking Description
Metabolomic analysis will be performed blinded to the exercise test results
Allocation
N/A
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing exercise oximetry
Arm Type
Experimental
Arm Description
Patients with PAD referred for treadmill testing and exercise oximetry will have a capillary blood sampling from the earlobe
Intervention Type
Biological
Intervention Name(s)
Capillary blood sampling from the earlobe
Intervention Description
Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period
Primary Outcome Measure Information:
Title
Chances in the metabolomic signature of arterial claudication by capillary blood sampling from the earlobe
Description
Search a significant difference between biological markers before and after the test during a walk on a treadmill
Time Frame
Half an hour (includes the resting walking and recovery period of exercise)
Secondary Outcome Measure Information:
Title
Changes inthe correlation of observed metabolomic variations and the importance of ischemia evaluated by oximetry
Description
Evaluate the coefficient of correlation between the changes of metabolomic pârameters and the sum of the observed DROPmin values of all studied subjects.
Time Frame
Half an hour (includes the resting walking and recovery period of exercise)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre ABRAHAM, MD, Ph.D
Organizational Affiliation
University Hospital in Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier universitaire
City
Angers
ZIP/Postal Code
49933
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
BIOlogical Response to Exercise : A Metabolomic Study in Peripheral Artery Disease (BIOR)
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