Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-09 @ 9:19 PM
Study NCT ID:
NCT02973867
Status:
UNKNOWN
Last Update Posted:
2016-11-28
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myokines Role During Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-24', 'studyFirstSubmitDate': '2016-11-22', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'myosin concentration', 'timeFrame': '1 day', 'description': 'blood measure'}], 'secondaryOutcomes': [{'measure': 'adipokines concentration', 'timeFrame': '1 day', 'description': 'blood measure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bone mineral density', 'Myokines', 'Adipokines'], 'conditions': ['Obesity, Adolescent']}, 'descriptionModule': {'briefSummary': 'We showed, for the first time, that Z-score increase during obesity was dependent on sex, severity of obesity and age but also on the bone site. Although the increase in BMD at bearing areas seems to be logically explained by the assumption that mechanical stresses have an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in BMD at non-load bearing areas such as the radius. These results suggest that changes in certain systemic compounds, induced by obesity, may interfere with bone metabolism. Moreover, the fact that the BMD or Z score is positively and only correlated with muscle mass and not with fat mass confirm that mechanical stresses are not the only factors acting on bone tissue.\n\nOur objectives are to determine the relationship between plasma concentration of myokines, adipokines, bone markers and BMD in obese subjects.', 'detailedDescription': 'We showed, for the first time, that Z-score increase during obesity was dependent on sex, severity of obesity and age but also on the bone site. Although the increase in BMD at bearing areas seems to be logically explained by the assumption that mechanical stresses have an osteogenic effect on bone tissue, BMD can in no way respond to the concomitant increase in BMD at non-load bearing areas such as the radius. (Maïmoun L and Col Bone 2015 Dec 1. S8756-3282 (15) 00421-4). These results suggest that changes in certain systemic compounds, induced by obesity, may interfere with bone metabolism. Moreover, the fact that the BMD or Z score is positively and only correlated with muscle mass and not with fat mass confirm that mechanical stresses are not the only factors acting on bone tissue.\n\nOur objectives are to determine the relationship between plasma concentration of myokines, adipokines, bone markers and BMD in obese subjects.\n\nOur objectives are to determine the relationship between plasma concentration of myokines (myostatin, follistatin), adipokines (leptin, adiponectin) and bone markers (CTX, Trap5, P1NP, ostéocalcin) in a cohort of obese patients, with differents obesity severity, differents ages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'obese patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obese patients age above 18 years old\n\nExclusion Criteria:\n\n* non agreement of inclusion'}, 'identificationModule': {'nctId': 'NCT02973867', 'acronym': 'Bonamy', 'briefTitle': 'Myokines Role During Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Myokines Role in Bone Mineral Density Increase During Obesity', 'orgStudyIdInfo': {'id': 'UF9768'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort called Elodie', 'description': 'Obese patients'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'SULTAN ARIANE', 'role': 'CONTACT', 'email': 'a-sultan@chu-montpellier.fr', 'phone': '467338402', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'SULTAN ARIANE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}