Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Determinants of the Vascular Response to Training in Chronic Obstructive Pulmonary Disease (COPD) Patients (cDysEndoBPCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774238
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Vascular comorbidities constitute a major burden in COPD patients. The atherosclerosis process is preceded by the onset of an endothelial dysfunction (assessed by the flow-mediated dilatation (FMD)), which is a risk factor for later ischemic vascular complications and death. In COPD, this endothelial dysfunction could be explained by intrinsic endothelial cell properties, or the effect of a pathogenic endothelial cell microenvironment (inflammation and/or oxidative stress). While exercise training is an efficient intervention in COPD patients, its vascular effect appear blunted. The endothelial function response to training has appeared heterogeneous in COPD patients, and possibly linked to the endothelial cel lesion. Thus, endothelial function (assessed by the FMD) response to exercise training would be lower in COPD patients with a baseline impairment of the their FMD. In addition, of biological and functional factors could explained the magnitude of the FMD response in COPD patients.The aim of the study is thus :

To compare the FMD change in COPD patients with FMD above and under the median FMD after 4 weeks of exercise training in the whole study population.

To test the association between the magnitude of the FMD changes after training and biological, functional and clinical factors (inflammation oxidative stress markers, endothelial biomarkers, pulmonary impairment and phenotype, cardiovascular risks factors, vascular function, metabolic markers, physical activity level, …)


Condition or disease Intervention/treatment Phase
COPD Patients Other: FMD analysis Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Biological and Functional Determinants of the Endothelial and Vascular Response to Exercise Training in COPD Patients
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
COPD patients
FMD analysis
Other: FMD analysis
Blood sample and vascular exploration.




Primary Outcome Measures :
  1. Measure of Flow-Mediated Dilatation (FMD) [ Time Frame: 4 +/- 2 weeks ]
    Measure of FMD by EndoPAT2000©


Secondary Outcome Measures :
  1. Measure of biological vascular markers [ Time Frame: 4 +/- 2 weeks ]
    E-selectin soluble (sE-sel, ng/mL)

  2. Measure of biological vascular markers [ Time Frame: 4 +/- 2 weeks ]
    Angiopoietin 1 (Ang-1, ng/mL)

  3. Measure of biological vascular markers [ Time Frame: 4 +/- 2 weeks ]
    Angiopoietin 2 (Ang-2, ng/mL)

  4. Measure of biological vascular markers [ Time Frame: 4 +/- 2 weeks ]
    von Willebrand factor (vWF, IU/dL)

  5. Measure of biological vascular markers [ Time Frame: 4 +/- 2 weeks ]
    Endothelin1 (ET1, pg/mL)

  6. Measure of biological vascular markers [ Time Frame: 4 +/- 2 weeks ]
    vascular endothelial growth factor A (VEGF-A, pg/mL)

  7. Measure of biological vascular markers [ Time Frame: 4 +/- 2 weeks ]
    Fms-like tyrosine kinase receptor 1 soluble (sFlt-1, pg/mL])

  8. Function vascular markers [ Time Frame: 4 +/- 2 weeks ]
    Intima-media thickness (in mm)

  9. Function vascular markers [ Time Frame: 4 +/- 2 weeks ]
    Pulse-wave velocity (in ms-1)

  10. Function vascular markers [ Time Frame: 4 +/- 2 weeks ]
    Systolic pressure index (in AU)

  11. Measure of systemic inflammatory markers [ Time Frame: 4 +/- 2 weeks ]
    high-sensitivity C-reactive protein (hs-CRP) (mg/dL)

  12. Measure of systemic inflammatory markers [ Time Frame: 4 +/- 2 weeks ]
    Tumor Necrosis Factor (TNF-a) (µg/mL)

  13. Measure of systemic inflammatory markers [ Time Frame: 4 +/- 2 weeks ]
    Interleukin-1 (IL-1) (in pg/ml)

  14. Measure of systemic inflammatory markers [ Time Frame: 4 +/- 2 weeks ]
    Interleukin-6 (IL-6) (in pg/ml)

  15. Measure of oxidative stress markers [ Time Frame: 4 +/- 2 weeks ]
    Lipid peroxidation (μmol/L)

  16. Measure of oxidative stress markers [ Time Frame: 4 +/- 2 weeks ]
    Plasma-free and esterified isoprostanes (pg/ml)

  17. Measure of oxidative stress markers [ Time Frame: 4 +/- 2 weeks ]
    Glutathione (GSH)/glutathione disulfide (GSSG) ratio (in AU)

  18. Measure of oxidative stress markers [ Time Frame: 4 +/- 2 weeks ]
    Antioxidant enzymatic (catalase, glutathione peroxidase, in International Unit (UI/gHb))

  19. Muscle function assessment [ Time Frame: 4 +/- 2 weeks ]
    Maximum isometric voluntary contraction (knee-flexion: 90°, in N.m)

  20. Muscle function assessment [ Time Frame: 4 +/- 2 weeks ]
    Endurance time (load : 30% of the maximum strength, in sec)

  21. Exercise capacity parameters [ Time Frame: 4 +/- 2 weeks ]
    Six minute walking distance (in meters)

  22. Exercise capacity parameters [ Time Frame: 4 +/- 2 weeks ]
    Exercise and rest blood pressure (in mmHg)

  23. Exercise capacity parameters [ Time Frame: 4 +/- 2 weeks ]
    Maximal oxygen uptake (VO2max, in mL/kg/min)

  24. Assessment of fasting metabolic parameters [ Time Frame: 4 +/- 2 weeks ]
    Glycemia (in mmol/L)

  25. Assessment of fasting metabolic parameters [ Time Frame: 4 +/- 2 weeks ]
    Insulinemia (in pmol/L)

  26. Assessment of fasting metabolic parameters [ Time Frame: 4 +/- 2 weeks ]
    Triglycerides (mmol/L)

  27. Assessment of fasting metabolic parameters [ Time Frame: 4 +/- 2 weeks ]
    Cholesterol (mmol/L)

  28. Assessment of fasting metabolic parameters [ Time Frame: 4 +/- 2 weeks ]
    HDL cholesterol (mmol/L)

  29. Assessment of fasting metabolic parameters [ Time Frame: 4 +/- 2 weeks ]
    LDL cholesterol (mmol/L)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 35 and 85 years old
  • COPD patients with a spirometry confirmed diseased
  • COPD patients with an indication for a pulmonary rehabilitation program
  • written and informed consent for this study signed by the patient

Exclusion Criteria:

  • Unstabilized comorbidity
  • Subject in a period of exclusion relative to another protocol
  • Major protected by law
  • Subject participating in another research protocol
  • Subject not affiliated to a social security scheme
  • Pregnant or lactating woman
  • Patient deprived of freedom by court or administrative order

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774238


Contacts
Layout table for location contacts
Contact: Fares Gouzi, MD, PhD +33467335908 f-gouzi@chu-montpellier.fr

Locations
Layout table for location information
France
Montpellier and Nimes University Hospitals Recruiting
Montpellier, France, 34295
Contact: Fares Gouzi, MD, phD    +33 4 67 33 59 08    f-gouzi@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Fares Gouzi, MD, PhD UH Montpellier
Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03774238    
Other Study ID Numbers: UF7699
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Flow-mediated dilatation
COPD
Pulmonary Rehabilitation
Comorbidities
endothelial cell
oxidative stress