Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT01395602
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2011-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Cabergoline on Weight and Glucose Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077465', 'term': 'Cabergoline'}], 'ancestors': [{'id': 'D004873', 'term': 'Ergolines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2011-07-14', 'studyFirstSubmitQcDate': '2011-07-14', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body weight', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'glucose', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Body Weight', 'Impaired Glucose Tolerance in Obese']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the efficacy of cabergoline, a long-acting dopamine receptor agonist, on body weight and blood glucose in healthy obese adults.\n\nThis is a randomized double-blind placebo controlled study. Twenty subjects each will be randomly assigned either placebo or cabergoline for 16 weeks.\n\nThe effect of treatment on body weight and blood glucose and insulin levels will be compared in the treatment versus the placebo arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 - 55 years\n* BMI 30 -40\n\nExclusion Criteria:\n\n* diabetes,\n* clinically significant medical condition,\n* use of medications that effect blood glucose or body weight'}, 'identificationModule': {'nctId': 'NCT01395602', 'briefTitle': 'Effect of Cabergoline on Weight and Glucose Tolerance', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Randomized Controlled Pilot Study of the Effect of Cabergoline on Body Weight and Glucose Tolerance in Healthy Obese Adults', 'orgStudyIdInfo': {'id': 'IRB #13952'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo pill', 'interventionNames': ['Other: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cabergoline', 'description': 'cabergoline pill', 'interventionNames': ['Drug: Cabergoline']}], 'interventions': [{'name': 'Cabergoline', 'type': 'DRUG', 'description': 'cabergoline 0.5 mg twice weekly', 'armGroupLabels': ['cabergoline']}, {'name': 'placebo', 'type': 'OTHER', 'description': '1 pill twice weekly', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Judith Korner, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Judith Korner', 'investigatorAffiliation': 'Columbia University'}}}}