Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT00998712
Status:
UNKNOWN
Last Update Posted:
2013-08-29
First Post:
2009-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood and urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-28', 'studyFirstSubmitDate': '2009-10-16', 'studyFirstSubmitQcDate': '2009-10-19', 'lastUpdatePostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endothelial function', 'timeFrame': 'same day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gestational diabetes mellitus', 'pregnancy', 'cardiovascular disease risk'], 'conditions': ['Gestational Diabetes Mellitus', 'Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to look at whether there are differences in blood vessel function, risk for developing diabetes (high blood sugar), lipid (blood fat) levels, and levels of other blood markers between black women and white women who have or do not have gestational diabetes mellitus.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Black and white women currently in the thrid trimester of a pregnancy complicated or uncomplicated by gestational diabetes.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy women of self-identified African descent (black) and European (white) ancestry,\n* 18-40 years of age,\n* Body mass index \\< 35 kg/m2\n* History of regular menstrual cycles,\n* Are currently pregnant and in third trimester of pregnancy (after 24 weeks gestational age)\n* Have no pregnancy-associated complications to-date\n* Are in good health free of hypertension, as well as thyroid, cardiac, or renal disease.\n\nExclusion Criteria:\n\n* History of smoking\n* Are taking potentially vasoactive medications'}, 'identificationModule': {'nctId': 'NCT00998712', 'briefTitle': 'Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction', 'orgStudyIdInfo': {'id': '2009P001255'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Black women in the third trimester of a pregnancy complicated by gestational diabetes.'}, {'label': '2', 'description': 'Black women in the third trimester of a normal, uncomplicated pregnancy.'}, {'label': '3', 'description': 'White women in the third trimester of a pregnancy complicated by gestational diabetes.'}, {'label': '4', 'description': 'White women in the third trimester of a normal, uncomplicated pregnancy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rhonda Bentley-Lewis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mark Creager, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Nathan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Florence Brown, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Brigham and Women's Hospital, Massachusetts General Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Research Assistant', 'role': 'CONTACT', 'email': 'RBLResearchGroup@partners.org', 'phone': '617-724-3504'}, {'name': 'Rhonda Bentley-Lewis, MD, MBA', 'role': 'CONTACT', 'email': 'rbentleylewis@partners.org', 'phone': '617-726-2874'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rhonda Bentley-Lewis, MD, MBA, MMSc', 'investigatorFullName': 'Rhonda Bentley-Lewis, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}