Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-24 @ 5:35 PM
Study NCT ID:
NCT02380950
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2015-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Moderate Alcohol Consumption to Cognitive Functioning After Roux-en Y Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'lastUpdateSubmitDate': '2015-03-02', 'studyFirstSubmitDate': '2015-02-19', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in reaction time after alcohol consumption', 'timeFrame': 'Change measures (baseline, 10 min, 45 min)'}]}, 'conditionsModule': {'conditions': ['Bariatric Surgery', 'Alcohol Consumption', 'Cognitive Function']}, 'descriptionModule': {'briefSummary': 'Objectives: Alcohol metabolism is changed in gastric bypass patients, leading to faster resorption and higher alcohol peak concentrations in blood. Because of stronger alcohol effects after gastric bypass we suggest that also general cognitive function is stronger impaired.\n\nMaterials and Methods: We included 28 females (12 gastric bypass patients, 8 obese and 8 normal weight subjects) in the study. Each participant had to drink 250 ml white wine. Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm. During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes with breathalyser "Dräger Alcotest 7510".'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGastric bypass group:\n\n* women\n* preOP BMI \\>35 kg/m²\n* time since bariatric surgery \\> 1 year\n* age 18-60 years\n* moderate drinking habits\n\nobese group:\n\n* women\n* BMI \\>35 kg/m²\n* age 18-60 years\n* moderate drinking habits\n\nnormal weight group:\n\n* women\n* BMI 18.5 - 25 kg/m²\n* age 18-60 years\n* moderate drinking habits\n\nExclusion Criteria:\n\n* men\n* patient does not drink wine\n* usage of psychotropic drugs\n* alcoholic\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02380950', 'briefTitle': 'Effect of Moderate Alcohol Consumption to Cognitive Functioning After Roux-en Y Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'eSwiss Medical & Surgical Center'}, 'orgStudyIdInfo': {'id': 'EKSG 13/046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '250 ml alcohol consumption', 'description': 'Each participant had to drink 250 ml white wine. Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm. During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes with breathalyser "Dräger Alcotest 7510".', 'interventionNames': ['Behavioral: 250 ml alcohol consumption']}], 'interventions': [{'name': '250 ml alcohol consumption', 'type': 'BEHAVIORAL', 'description': 'Each participant had to drink 250 ml white wine. Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm. During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes with breathalyser "Dräger Alcotest 7510".', 'armGroupLabels': ['250 ml alcohol consumption']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'eSwiss Medical & Surgical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Bernd Schultes', 'investigatorFullName': 'Bernd Schultes', 'investigatorAffiliation': 'eSwiss Medical & Surgical Center'}}}}