Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2026-01-31 @ 2:20 AM
Study NCT ID:
NCT02112695
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2014-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid System Cerebral Activity in Endurance Sportswomen - Addiction or Denutrition ? [11C]Diprenorphine PET Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-25', 'studyFirstSubmitDate': '2014-04-10', 'studyFirstSubmitQcDate': '2014-04-11', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '[11C]diprenorphine binding potential', 'timeFrame': '2 weeks', 'description': 'Value of \\[11C\\]diprenorphin binding potential in predifined brains regions. \\[11C\\]diprenorphin BP will be evaluated by brain positron emission tomography and MRI exam'}], 'secondaryOutcomes': [{'measure': 'correlation [11C]diprenorphine BP', 'timeFrame': '2 weeks', 'description': 'Correlation between \\[11C\\]Diprenorphine binding potential and plasma endogenous opioid levels'}, {'measure': 'correlation [11C]diprenorphine BP', 'timeFrame': '2 weeks', 'description': 'Correlation between \\[11C\\]Diprenorphine binding potential and psychometric score evaluating addictive behavior, reward and positive reinforcement'}, {'measure': 'correlation [11C]diprenorphine BP', 'timeFrame': '2 weeks', 'description': 'Correlation between \\[11C\\]Diprenorphine binding potential and appetite regulating hormones'}, {'measure': 'correlation [11C]diprenorphine BP', 'timeFrame': '2 weeks', 'description': 'Correlation between \\[11C\\]Diprenorphine binding potential and LH response during GnRH test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endurance sportswomen', 'addiction', 'undernutrition', '[11C]diprenorphine Pet', 'pituitary region'], 'conditions': ['Sports Nutritional Sciences']}, 'descriptionModule': {'briefSummary': 'Abnormal opioid system have been identified in addictive behavior and activity of the opioid system has also shown a strong link with the nutritional balance. A significant increase in endorphin levels was noticed after exercise, proportional to the duration and intensity of this activity. One brain imaging study showed an increase in opioid activity in athletes after endurance training. However , a decrease in opioid tone related to receptor desensitization in the brain has been raised in the sport and it is possible to feel like , the subject must perform physical exercise more frequently . Consequently, in order to deepen the hypothesis of addiction in high-level sport , the brain opioid activity should be assessed pre- training compared to a group of sedentary control subjects .\n\nPreliminary results of a previous study the investigators are conducting on anorexia nervosa (AN ) show abnormalities that appear to be involved in self addiction anorexia nervosa and the regulation of gonadal function. However, the relation of cause and effect between these anomalies and undernutrition remains to be determined . Given the addictive component in the endurance sport and the variability of the nutritional status of its practitioners , evaluation of brain activity in these subjects could provide additional answers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor High-level sportswomen :\n\n* 18-35-year-old\n* High-level sportswomen\n* BMI\\>19kg/m2\n* Absence of eating disorders\n* In pre-competition period\n* Signature of written consent\n\nFor controls :\n\n* 18-35-year-old\n* Sedentary normal weight women\n* BMI\\>19kg/m2\n* Normal nutritional markers\n* Absence of eating disorders or other psychiatric or organic diseases\n\nExclusion Criteria:\n\n* Oral contraception\n* Heart failure\n* Neuroleptics, antiparkinson drugs, alpha-methyl-dopa, beta blockers, inhibitors of monoamine oxidase-A or MOA-B, tricyclic antidepressants, selective serotonin reuptake inhibitor, thyme-regulators (lithium), anticonvulsant drugs, codeine, morphine, drugs containing tramadol, dopaminergic drugs'}, 'identificationModule': {'nctId': 'NCT02112695', 'briefTitle': 'Opioid System Cerebral Activity in Endurance Sportswomen - Addiction or Denutrition ? [11C]Diprenorphine PET Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Opioid System Cerebral Activity in Endurance Sportswomen - Addiction or Denutrition ? [11C]Diprenorphine PET Study', 'orgStudyIdInfo': {'id': '1208051'}, 'secondaryIdInfos': [{'id': '2013-004733-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sportswomen', 'description': '3 micrograms \\[11C\\]diprenorphine', 'interventionNames': ['Other: [11C]diprenorphine']}, {'type': 'EXPERIMENTAL', 'label': 'control subjects', 'description': '3 micrgrams \\[11C\\]diprenorphine', 'interventionNames': ['Other: [11C]diprenorphine']}], 'interventions': [{'name': '[11C]diprenorphine', 'type': 'OTHER', 'otherNames': ['radiopharmacentical precursor solution'], 'description': '3 micrograms \\[11C\\]diprenorphine - intravenous use - 1 time', 'armGroupLabels': ['control subjects', 'sportswomen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': "Service d'Endocrinologie - CHU Saint-Etienne", 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Bruno Estour, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}