Involvement of Plasmatic Factors in the Peripheral Muscle Dysfunction of COPD Patients - In Vitro Study
1 other identifier
observational
18
1 country
1
Brief Summary
Chronic Obstructive Pulmonary Patients is a defined by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. It is associated with an atrophy of the skeletal muscle that impairs the patient's prognosis. The biological mechanisms of this muscle atrophy have not been elucidated, and the "spill-over theory" has recently emerged. Indeed, in COPD patients, the pulmonary inflammation is associated with a systemic low-grade inflammation, and the increased pro-inflamatory molelcules in the blood - which constitute the cellular micro-environement of the muscle fibre - could activate the mechanisms of the cell atrophy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedStudy Start
First participant enrolled
July 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedApril 18, 2019
September 1, 2018
1.5 years
June 21, 2017
April 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myotube diameter of in vitro cultured myotubes
Myotube diameter of in vitro cultured myotubes from healthy subjects, exposed to the serum of healthy controls and COPD patients
6 days
Secondary Outcomes (1)
Expression and translation of markers of
6 days
Other Outcomes (1)
Level of pro-Inflamatory markers
6 days
Study Arms (2)
Healthy subjects
Determination of pro-inflammatory plasma factors at Healthy subjects aged from 35 to 85 years old
COPD patients
Determination of pro-inflammatory plasma factors at COPD patients aged from 35 to 85 years old
Interventions
Determination of pro-inflammatory plasma factors at COPD patients aged from 35 to 85 years old and Healthy subjects aged from 35 to 85 years old
Eligibility Criteria
Chronic Obstructive Pulmonary Patients
You may qualify if:
- to 85 years old
- COPD patients: association of symtoms (breathlessness, cough, sputum) and chronic exposure to inhalated risk factors (like tobacco smoke) and a FEV1/VC ratio \<70% assessed by a spirometry
- Healthy subjects: A sedentariness assessed by a Voorrips score \<9.4 and/or a report of \<150 min/week of moderate-to-vigorous physical activity
You may not qualify if:
- A recent COPD exacerbation (\< 4weeks)
- The decompensation of a comorbidity
- An antioxidant supplementation or medication
- A long-term systemic corticosteroid medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uhmontpellier
Montpellier, 34290, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maurice HAYOT, MD, PhD
University Hospital, Montpellier
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2017
First Posted
June 23, 2017
Study Start
July 6, 2017
Primary Completion
December 31, 2018
Study Completion
January 31, 2019
Last Updated
April 18, 2019
Record last verified: 2018-09