Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-28 @ 9:31 AM
Study NCT ID:
NCT00842569
Status:
COMPLETED
Last Update Posted:
2009-02-12
First Post:
2009-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Electrophysiological Patterns in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': {'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'lastUpdateSubmitDate': '2009-02-11', 'studyFirstSubmitDate': '2009-02-11', 'studyFirstSubmitQcDate': '2009-02-11', 'lastUpdatePostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of amplitudes and latencies of the P300 complex of Event Related Potential during an oddball paradigm, in normal-weighted and obese subjects'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obesity', 'cognitive process', 'reward', 'P300', 'ERP', 'Event-related potential during oddball paradigm', 'brain electrophysiological patterns', 'externalizing factor'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '10418702', 'type': 'BACKGROUND', 'citation': 'Bauer LO, Hesselbrock VM. P300 decrements in teenagers with conduct problems: implications for substance abuse risk and brain development. Biol Psychiatry. 1999 Jul 15;46(2):263-72. doi: 10.1016/s0006-3223(98)00335-7.'}, {'pmid': '16629688', 'type': 'BACKGROUND', 'citation': 'Patrick CJ, Bernat EM, Malone SM, Iacono WG, Krueger RF, McGue M. P300 amplitude as an indicator of externalizing in adolescent males. Psychophysiology. 2006 Jan;43(1):84-92. doi: 10.1111/j.1469-8986.2006.00376.x.'}, {'pmid': '16644137', 'type': 'BACKGROUND', 'citation': 'Yoon HH, Iacono WG, Malone SM, McGue M. Using the brain P300 response to identify novel phenotypes reflecting genetic vulnerability for adolescent substance misuse. Addict Behav. 2006 Jun;31(6):1067-87. doi: 10.1016/j.addbeh.2006.03.036. Epub 2006 Apr 27.'}]}, 'descriptionModule': {'briefSummary': 'There is growing evidence of behavioural and neurobiological overlaps between obesity and drug abuse. Reduction of the amplitude of P300, a component of event-related potentials (ERP) elicited by an oddball paradigm, is an electrophysiological characteristic and a marker of vulnerability in substance abuse. We want to determine whether obesity is associated with such electrophysiological features during an auditory oddball paradigm. We postulate that obesity could be associated with electrophysiological abnormalities that could be viewed as a possible vulnerability marker for food addiction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'a healthy but normal-weighted or obese population. Depressive state or eating disorders were carefully evaluated.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria for the study are men and women aged 20-60 years, BMI 18.5-24.9 kg/m2 for control subjects and BMI\\>30 kg/m2 for obese subjects, stable body weight over the previous 3 months, report of sedentary or moderate physical activity\n\nExclusion Criteria:\n\n* The exclusion criteria are pregnancy, post-menopausal women, any physiological or psychological illness that could influence the results, subjects likely to take medical drugs interfering with the electrophysiological parameters of the study, diabetes, hearing disorder, intense physical activity and report or evidence of excessive alcohol consumption, depressive state or eating disorders according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).'}, 'identificationModule': {'nctId': 'NCT00842569', 'briefTitle': 'Brain Electrophysiological Patterns in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Centre de Recherche en Nutrition Humaine Rhone-Alpe'}, 'officialTitle': 'ERP Study of Brain Electrophysiological Patterns in Obesity', 'orgStudyIdInfo': {'id': 'CRNHRA-09-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal weighted', 'description': 'BMI\\<25'}, {'label': 'Obese', 'description': 'BMI\\>30'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'F69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre de Recherche en Nutrition Humaine Rhone Alpes', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Emmanuel DISSE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CRNH Rhone-Alpes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre de Recherche en Nutrition Humaine Rhone-Alpe', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Emmanuel DISSE', 'oldOrganization': 'Centre de Recherche en Nutrition Humaine Rhone-Alpe'}}}}