Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-25 @ 3:31 PM
Study NCT ID:
NCT00725166
Status:
COMPLETED
Last Update Posted:
2009-06-11
First Post:
2008-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Muscle Gene Expression Profiles in Young and Old Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, muscle'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-09', 'studyFirstSubmitDate': '2008-07-29', 'studyFirstSubmitQcDate': '2008-07-29', 'lastUpdatePostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To identify the differential expression profiles (proteomics, transcriptomics) in skeletal muscle between young and old men', 'timeFrame': 'During biopsie (W3)'}], 'secondaryOutcomes': [{'measure': 'To specify the localisation of the major biomarkers in the muscle biopsies.', 'timeFrame': 'During biopsie (W3)'}, {'measure': 'To compare muscular energy metabolic enzymatic activities between young and old men', 'timeFrame': 'during biopsie (W3)'}, {'measure': 'To compare the number of muscular stem cells between young and old men', 'timeFrame': 'during biopsie (W3)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aging', 'Biopsy', 'Skeletal muscle', 'Molecular biology', 'Genetic markers', 'Gene expression regulation', 'Young and old men', 'Healthy volunteers'], 'conditions': ['Elderly', 'Sarcopenia']}, 'descriptionModule': {'briefSummary': 'To reach the goals of living longer in better medical conditions, many countries reach the same conclusion: new strategies have to be developed to avoid, or at least limit, the effects of age; this requires a better knowledge of the mechanisms of aging. Our project focuses on the loss of muscle mass associated with aging, called sarcopenia. Sarcopenia unavoidably leads to impaired mobility and poor balance, which contributes to loss of functional autonomy and to increased prevalence for severe falls. Skeletal muscle also plays a central role as a reserve for energy and amino acids. Hence, sarcopenia further triggers severe side metabolic effects such as frailty among elderly persons. The precise mechanisms of muscle aging are still mostly unknown, although many theories have been proposed.\n\nThe present study aims at better understanding the mechanisms of skeletal muscle loss associated with aging. Using muscle biopsies from young and old subjects, the differential expression profiles of mRNA will be obtained through chips that will evaluate more than 39000 transcripts. On the same samples, proteomic analyses will involve two complementary approaches: (1) bidimensional electrophoresis (2DGE) coupled to mass spectrometry (MALDI-ToF) for dominant proteins; (2) Western-blot (more than 800 antibodies) targeting regulating proteins not detectable using 2DGE. Complementary histological studies (immunohisto-fluorescence, confocal microscopy) will specify the localisation of the major biomarkers in the muscle biopsies.\n\nThe results of that research will have applications in the medium term and will lead to nutritional interventions to modulate specific metabolic pathways and improve the quality of life in the elderly.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Young : students of the Saint-Etienne's university. Old : men who participate in the PROOF study", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Affiliated or beneficiary of a social security category\n* Having signed the inform consent form\n* Having signed the genetic consent form\n\nExclusion Criteria:\n\n* Antiaggregant platelet treatment\n* Type 2 diabetes\n* Body Mass Index \\> 25\n* Severe renal disease\n* CRP \\> 10\n* Abnormal clotting test\n* Allergies to local anesthetics'}, 'identificationModule': {'nctId': 'NCT00725166', 'acronym': 'CERA', 'briefTitle': 'Human Muscle Gene Expression Profiles in Young and Old Men', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Human Muscle Gene Expression Profiles in Young and Old Men', 'orgStudyIdInfo': {'id': '0708102'}, 'secondaryIdInfos': [{'id': '2008-A00374-51'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Young', 'description': 'Young men 19-25 years old', 'interventionNames': ['Other: Skeletal muscle aging']}, {'label': 'Old', 'description': 'old men 70-76 years old, who participate in the PROOF study (NCT 00759304)', 'interventionNames': ['Other: Skeletal muscle aging']}], 'interventions': [{'name': 'Skeletal muscle aging', 'type': 'OTHER', 'description': 'W1 - Blood test\n\n* Maximal voluntary contraction of quadriceps\n* Hydrostatic weighing\n\nW2 - Maximal metabolic test using a cycloergometer\n\nW3 - Muscular biopsy', 'armGroupLabels': ['Old', 'Young']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Daniel BECHET, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'INRA Clermont-Ferrand'}, {'name': 'Jean-Claude BARTHELEMY, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': "Fondation des Caisses d'Epargne Rhône-Alpes", 'class': 'UNKNOWN'}, {'name': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Clément CAILLAUX', 'oldOrganization': 'CHU de Saint-Etienne'}}}}