Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-04 @ 10:25 AM
Study NCT ID:
NCT00576394
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2007-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2007-12-18', 'studyFirstSubmitQcDate': '2007-12-18', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Hypoglycemia', 'timeFrame': '24 hours following surgery'}], 'secondaryOutcomes': [{'measure': 'free fatty acid levels', 'timeFrame': '24 hours following surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glucose, Insulin'], 'conditions': ['Glycemic Control']}, 'referencesModule': {'references': [{'pmid': '21865944', 'type': 'RESULT', 'citation': 'Lazar HL, McDonnell MM, Chipkin S, Fitzgerald C, Bliss C, Cabral H. Effects of aggressive versus moderate glycemic control on clinical outcomes in diabetic coronary artery bypass graft patients. Ann Surg. 2011 Sep;254(3):458-63; discussion 463-4. doi: 10.1097/SLA.0b013e31822c5d78.'}]}, 'descriptionModule': {'briefSummary': 'entGlycemic control has been found to improve clinical outcomes following Coronary Bypass Surgery. This study tests the hypothesis that obtaining tighter glycemic control(80-120mg/dl) as opposed to more moderate control (120-180mg/dl) will further improve outcomes.', 'detailedDescription': '150 diabetic patients will be randomized to achieve aggressive glycemic control (80-120mg/dl) vs moderate control (120-180mg/dl) using intravenous insulin infusions beginning at anesthetic induction and continuing for 18 hours following surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All diabetic patients undergoing Coronary Bypass Surgery\n\nExclusion Criteria:\n\n* Patients with hepatic and renal failure'}, 'identificationModule': {'nctId': 'NCT00576394', 'briefTitle': 'Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients', 'organization': {'class': 'OTHER', 'fullName': 'American Heart Association'}, 'officialTitle': 'Impact of Aggressive Versus Moderate Glycemic Control on Clinical Outcomes Following Coronary Artery Bypass Graft Surgery in Diabetic Patients', 'orgStudyIdInfo': {'id': 'H-25760'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1Moderate Glycemic Control', 'description': 'Patients will receive an insulin drip to keep blood glucose levels between 120-180mg/dl', 'interventionNames': ['Drug: IV Insulin drip']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2Aggressive Glycemic Control', 'description': 'Patients will receive an insulin drip designed to maintain serum glucose between 80-120mg/dl', 'interventionNames': ['Drug: Insulin']}], 'interventions': [{'name': 'IV Insulin drip', 'type': 'DRUG', 'description': 'IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl', 'armGroupLabels': ['1Moderate Glycemic Control']}, {'name': 'Insulin', 'type': 'DRUG', 'description': 'IV insulin drip to keep serum glucose between 80-120mg/dl.', 'armGroupLabels': ['2Aggressive Glycemic Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Heart Association', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Cardiothoracic Surgery', 'investigatorFullName': 'Harold L. Lazar MD', 'investigatorAffiliation': 'American Heart Association'}}}}