Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
Study NCT ID:
NCT04229550
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2020-01-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolic Effects of One-weak Heavy Drinking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2016-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-12', 'studyFirstSubmitDate': '2020-01-08', 'studyFirstSubmitQcDate': '2020-01-12', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Altered cognitive function', 'timeFrame': 'First day after intervention week', 'description': 'Evaluated by validated cognitive test ("SCIP")'}], 'primaryOutcomes': [{'measure': 'Impairment of glucose tolerance', 'timeFrame': 'First day after intervention week', 'description': 'Evaluated by OGTT'}], 'secondaryOutcomes': [{'measure': 'Hepatic steatosis', 'timeFrame': 'First day after intervention week', 'description': 'Evaluated by abdominal ultrasound scan'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Disturbance', 'Alcohol; Harmful Use', 'Glucose Intolerance']}, 'descriptionModule': {'briefSummary': "Examination of the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.", 'detailedDescription': "Metabolic effects of intermittent unhealthy lifestyle in otherwise young healthy adults are poorly studied. The investigators evaluated the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.\n\nFestival participants were studied before and after participation (one week) in Roskilde Festival 2016 and matched with controls who lead a normal life for an equivalent period of time. An oral glucose tolerance test (OGTT), abdominal ultrasound and strain elastography for liver stiffness were performed together with a bioimpedance scan and cognitive tests."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI of 18,5-25 kg/m2\n* Normal liver function (assessed by ASAT, ALAT, GGT, alkaline phosphatase, albumin and bilirubin, coagulation factors II, VII and X, INR and platelets)\n\nExclusion Criteria:\n\n* Planning alcohol withdrawal or dieting/a special low-fat diet during Roskilde Festival\n* Diabetes or pre-diabetes\n* First degree relatives with diabetes\n* Kidney disease (eGFT\\<60 ml/min and/or albuminuria)\n* Chronic diseases (in addition to those already mentioned) that could affect participation in festival activities (concerts and parties)\n* Any condition in which the investigator believed would make it impossible to participate'}, 'identificationModule': {'nctId': 'NCT04229550', 'acronym': 'ROSMET', 'briefTitle': 'Metabolic Effects of One-weak Heavy Drinking', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Metabolic Effects of One-Week Heavy Drinking and Fast Food Intake During Roskilde Festival in Young Healthy Male Adults', 'orgStudyIdInfo': {'id': 'H-15019685'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control subjects', 'description': '1 week of normal daily life and only by the National Health Board recommendated alcohol consumption.'}, {'type': 'EXPERIMENTAL', 'label': 'Festival subjects', 'description': "1 week's participation in Roskilde Festival 2016", 'interventionNames': ['Behavioral: Festival participation']}], 'interventions': [{'name': 'Festival participation', 'type': 'BEHAVIORAL', 'description': "One week's participation in Roskilde Festival 2016 or living a normal daily life.", 'armGroupLabels': ['Festival subjects']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Filip K Knop, Prof,MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD', 'investigatorFullName': 'Filip Krag Knop', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}