Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-28 @ 8:32 AM
Study NCT ID:
NCT01918566
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2013-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Endogenous GLP-1 (Glycolipoprotein) in Regulating Glucose Stimulated Brain Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005106', 'term': 'Exploratory Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D005632', 'term': 'Fructose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-05', 'studyFirstSubmitDate': '2013-05-08', 'studyFirstSubmitQcDate': '2013-08-05', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional magnetic resonance imaging (fMRI) in healthy volunteers while they performed a working memory task: changes in cerebral blood flow and blood hormones from baseline to treatment', 'timeFrame': 'changes from baseline to one hour after treatment', 'description': 'Whole brain analysis with a cluster-level threshold was followed by an a priori defined region of interest analysis of the dorsolateral prefrontal cortex including a cluster-level threshold and family-wise error adjustment for multiple comparisons.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Exploratory Behavior']}, 'descriptionModule': {'briefSummary': 'Our objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI. Administration of glucose with and without lactisole and exendin as well as fructose is followed by functional brain MRI, and findings are correlated with serum GLP-1 levels as an endogenous satiety signal in humans.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* right-handed healthy males, no drugs, non-smoking\n\nExclusion Criteria:\n\n* drug abuse, smoker, left-handed, claustrophobia'}, 'identificationModule': {'nctId': 'NCT01918566', 'briefTitle': 'The Role of Endogenous GLP-1 (Glycolipoprotein) in Regulating Glucose Stimulated Brain Activity', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'The Role of Endogenous GLP-1 in Regulating Glucose Stimulated Brain Activity', 'orgStudyIdInfo': {'id': 'EKBB 298/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '300ml tap water', 'description': 'Single intragastric instillation of 300ml tap water via nasogastric tube', 'interventionNames': ['Dietary Supplement: tap water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glucose', 'description': 'Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube', 'interventionNames': ['Dietary Supplement: Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glucose plus Lactisole', 'description': 'Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole', 'interventionNames': ['Dietary Supplement: Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fructose', 'description': 'Single intragastric instillation of 25g Fructose in 300ml tap water via nasogastric tube', 'interventionNames': ['Dietary Supplement: 25g Fructose in 300ml tap water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glucose and Exendin', 'description': 'Single intragastric instillation of 75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39', 'interventionNames': ['Dietary Supplement: 75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39']}, {'type': 'SHAM_COMPARATOR', 'label': 'tap water, lactisole', 'description': 'Single intragastric instillation of 300ml tap water with 450ppm lactisole', 'interventionNames': ['Dietary Supplement: 300ml tap water with 450ppm lactisole']}], 'interventions': [{'name': 'tap water', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['300ml tap water']}, {'name': 'Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Glucose']}, {'name': 'Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Glucose plus Lactisole']}, {'name': '25g Fructose in 300ml tap water', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Fructose']}, {'name': '75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Glucose and Exendin']}, {'name': '300ml tap water with 450ppm lactisole', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['tap water, lactisole']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Christoph Beglinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}