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

NCT03305198 | Completed

• 1 other identifier: 2017-A01147-46
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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)

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (1)

Patients undergoing exercise oximetry

EXPERIMENTAL

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

Interventions

Capillary blood sampling from the earlobe BIOLOGICAL

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

Patients undergoing exercise oximetry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Patient able to walk on a treadmill
• Patient agrees to be involve in the protocol and sign the consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Centre hospitalier universitaire

Angers, 49933, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Pierre ABRAHAM, MD, Ph.D

  University Hospital in Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Metabolomic analysis will be performed blinded to the exercise test results
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Analysis of changes in metabolomic signature from rest to post exercise

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 9, 2017
• Study Start: October 1, 2017
• Primary Completion: March 18, 2019
• Study Completion: March 18, 2019
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

FR (1)