Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-02 @ 3:39 AM
Study NCT ID:
NCT02284932
Status:
UNKNOWN
Last Update Posted:
2016-09-08
First Post:
2014-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Atrophy In Patients With Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001284', 'term': 'Atrophy'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample and muscle biopsy of vastus lateralis (quadriceps)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-07', 'studyFirstSubmitDate': '2014-10-08', 'studyFirstSubmitQcDate': '2014-11-05', 'lastUpdatePostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease of protein degradation in muscles of wasted COPD patients', 'timeFrame': 'At baseline (COPD in a stable state of the disease)'}], 'secondaryOutcomes': [{'measure': 'Increase of protein synthesis in muscles of wasted COPD patients', 'timeFrame': 'At baseline (COPD in a stable state of the disease)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD', 'atrophy', 'muscle'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Limb muscle dysfunction, characterized by atrophy and weakness, is amongst the most troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to poor functional status and premature mortality.\n\nOne prevailing hypothesis stipulates that the deterioration in muscle structure and function during COPD results from a spillover of inflammatory mediators from the lungs to the systemic circulation and then to the muscles.', 'detailedDescription': 'The investigators objective is to investigate the impact of COPD on key signaling pathways involved in the muscle atrophy. Moderate to severe COPD patients (FEV1 under 60% of predicted) and healthy controls will be recruited. All of the investigators patients will undergo a thorough baseline assessment in pulmonary capacity, muscle force and body composition. Blood sampling and biopsy of the quadriceps will be done. Key proteins of signaling intramuscular pathways involved in protein synthesis and degradation will be measured in the quadriceps.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with COPD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* COPD with an FEV1 of under 60% of predicted\n* non-smoker\n* between 55 and 75 years old\n\nExclusion Criteria:\n\n* all inflammatory disease (HIV, cancer, renal and cardiac deficiency)\n* hormonal dysregulation\n* inferior limb pathology\n* neuromuscular pathology\n* history of tobacco or alcool abuse\n* oxygen dependent\n* recent exacerbation (2 months) of the symptoms of COPD'}, 'identificationModule': {'nctId': 'NCT02284932', 'briefTitle': 'Muscle Atrophy In Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Muscle Atrophy In Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'COPD-20739'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD patients', 'description': 'Group : COPD patients No specific intervention for this study', 'interventionNames': ['Other: No specific intervention for this study']}, {'label': 'Healthy controls', 'description': 'Group : healthy volunteers No specific intervention for this study', 'interventionNames': ['Other: No specific intervention for this study']}], 'interventions': [{'name': 'No specific intervention for this study', 'type': 'OTHER', 'description': 'No specific intervention for this study', 'armGroupLabels': ['COPD patients', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'François Maltais, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professionelle de recherche', 'investigatorFullName': 'Annie Dubé', 'investigatorAffiliation': 'Laval University'}}}}