Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT02675192
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2016-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Aging of Skeletal Muscles in Humans
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': 'Urinary and blood samples will be taken, and a muscle biopsy will be performed.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-16', 'studyFirstSubmitDate': '2016-01-25', 'studyFirstSubmitQcDate': '2016-02-02', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The area of type IIA fibers called vastus lateralis.', 'timeFrame': 'Day 15', 'description': 'The primary endpoint is the cross sectional area (measured in µm2) of type IIA fibers from the vastus lateralis muscle biopsies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sarcopenia', 'elderly', 'muscle biopsy'], 'conditions': ['HEALTHY']}, 'referencesModule': {'references': [{'pmid': '17898520', 'type': 'BACKGROUND', 'citation': "Barthelemy JC, Pichot V, Dauphinot V, Celle S, Laurent B, Garcin A, Maudoux D, Kerleroux J, Lacour JR, Kossovsky M, Gaspoz JM, Roche F. Autonomic nervous system activity and decline as prognostic indicators of cardiovascular and cerebrovascular events: the 'PROOF' Study. Study design and population sample. Associations with sleep-related breathing disorders: the 'SYNAPSE' Study. Neuroepidemiology. 2007;29(1-2):18-28. doi: 10.1159/000108914."}]}, 'descriptionModule': {'briefSummary': 'Aging affects almost all the tissues and physiological functions, and skeletal muscle is the most affected organ. The progressive decline of the weight and the muscular function linked to the aging contributes to the lack of autonomy and dependence, but also to an increase of the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in 13-24% of 60 years old, and 50% of 80 years old and more.\n\nHowever, strong inter-individual variations of this prevalence of sarcopenia exists. The key issue is to understand why the biological aging of the skeletal muscle is so different between people.\n\nIn this study, mechanisms involved in biological aging of the skeletal muscle in aging people (same chronological age) will be specified.', 'detailedDescription': 'Aging affects almost all the tissues and physiological functions, and skeletal muscle is the most affected organ. The progressive decline of the weight and the muscular function linked to the aging contributes to the lack of autonomy and dependence, but also to an increase of the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in 13-24% of 60 years old, and 50% of 80 years old and more.\n\nHowever, strong inter-individual variations of this prevalence of sarcopenia exists. Some elderly (60 years old) reveal a biological aging of 80 years old, whereas 60 years old people reveal a biological aging of 60 years old. The key issue is to understand why the biological aging of the skeletal muscle is so different between people.\n\nPrevious sarcopenia studies in Humans did not really focus on chronological aging, they were all based on a comparison between young and old people. No study considered inter-individual modifications (biological aging) in sarcopenia. Furthermore, few studies were associated in the same study to "omic", histological, and epigenetic data, to obtain integrated point of view of Human Sarcopenia.\n\nIn this study, mechanisms involved in biological aging of the skeletal muscle in aging people (same chronological age) will be specified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '83 Years', 'minimumAge': '80 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are recruited in the Proof cohort (Barthélemy et al., 2007).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Belonging to the Proof cohort\n* Between 80 and 83 years old\n* Informed consent signed\n* Genetic analyses consent signed\n* Subject affiliated or entitled to a social security scheme\n\nExclusion Criteria:\n\n* Anti coagulative treatment\n* Severe obesity (\\>35)\n* All chronic pathology requiring a treatment\n* Severe renal insufficiency (discovery less than 6 months)\n* Abnormal coagulation appraisal\n* Allergy to local anesthetics\n* Installation of a prosthetic hip and / or knee in the last six months\n* Senile dementia\n* Refusal of genetic study'}, 'identificationModule': {'nctId': 'NCT02675192', 'acronym': 'BioAge', 'briefTitle': 'Biological Aging of Skeletal Muscles in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Biological Aging of Skeletal Muscles in Humans, a Monocentric, Prospective Study', 'orgStudyIdInfo': {'id': '1508145'}, 'secondaryIdInfos': [{'id': '2015-A01484-45', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Proof cohort : muscular assessment', 'description': '* Clinical examination : Body weight, BMI, cardiac frequency, muscular examination,...\n* Blood appraisal : glycaemia, lipidic appraisal, leptin, albumin, coagulation, metabolome and epigenetic tests,...\n* Urinary collection : metabolome tests\n* Maximal voluntary quadriceps strength (MVC)\n* Checking muscle functional skills\n* Muscular biopsy', 'interventionNames': ['Other: Proof cohort : muscular assessment']}], 'interventions': [{'name': 'Proof cohort : muscular assessment', 'type': 'OTHER', 'description': 'Clinical examination, blood appraisal, urinary collection, MVC, checking muscle functional skills and muscular biopsy will be performed.', 'armGroupLabels': ['Proof cohort : muscular assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42100', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'FEASSON Léonard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ecole Nationale Superieure Lyon', 'class': 'UNKNOWN'}, {'name': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement", 'class': 'OTHER'}, {'name': 'Region Rhone Alpes', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}