Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT00282867
Status:
COMPLETED
Last Update Posted:
2009-08-21
First Post:
2006-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucose Regulation in Acute Stroke Patients (GRASP) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011188', 'term': 'Potassium'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D008672', 'term': 'Metals, Alkali'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kj4v@virginia.edu', 'phone': '434 924-5323', 'title': 'Karen C. Johnston, MD, MSc', 'organization': 'University of Virginia'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Favorable 3 Month Modified Rankin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tight Control Group', 'description': 'target glucose level 70-110 mg/dL'}, {'id': 'OG001', 'title': 'Loose Control Group', 'description': 'target glucose level 70 - 200 mg/dL'}, {'id': 'OG002', 'title': 'Usual Care Group', 'description': 'target level 70 - 300 mg/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': '3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tight Control Group', 'description': 'target glucose level 70-110 mg/dL'}, {'id': 'OG001', 'title': 'Loose Control Group', 'description': 'target glucose level 70 - 200 mg/dL'}, {'id': 'OG002', 'title': 'Usual Care Group', 'description': 'target level 70 - 300 mg/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 5 days', 'description': 'hypoglycemic events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Symptomatic Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tight Control Group', 'description': 'target glucose level 70-110 mg/dL'}, {'id': 'OG001', 'title': 'Loose Control Group', 'description': 'target glucose level 70 - 200 mg/dL'}, {'id': 'OG002', 'title': 'Usual Care Group', 'description': 'target level 70 - 300 mg/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 5 days', 'description': 'symptomatic hypoglycemia (glucose \\< 55 mg/dL)during treatment period', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Target Glucose Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tight Control Group', 'description': 'target glucose level 70-110 mg/dL'}, {'id': 'OG001', 'title': 'Loose Control Group', 'description': 'target glucose level 70 - 200 mg/dL'}, {'id': 'OG002', 'title': 'Usual Care Group', 'description': 'target level 70 - 300 mg/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'first 24 hours after initiation of treatment', 'description': 'glucose in target range in first 24 hours', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol no analysis of this endpoint was performed in the "usual care" group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tight Control Group', 'description': 'target glucose level 70-110 mg/dL'}, {'id': 'FG001', 'title': 'Loose Control Group', 'description': 'target glucose level 70 - 200 mg/dL'}, {'id': 'FG002', 'title': 'Usual Care Group', 'description': 'target level 70 - 300 mg/dL'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'd/c prior to prim outcome, 3 m f/u done', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tight Control Group', 'description': 'target glucose level 70-110 mg/dL'}, {'id': 'BG001', 'title': 'Loose Control Group', 'description': 'target glucose level 70 - 200 mg/dL'}, {'id': 'BG002', 'title': 'Usual Care Group', 'description': 'target level 70 - 300 mg/dL'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-15', 'studyFirstSubmitDate': '2006-01-26', 'resultsFirstSubmitDate': '2009-07-14', 'studyFirstSubmitQcDate': '2006-01-26', 'lastUpdatePostDateStruct': {'date': '2009-08-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-15', 'studyFirstPostDateStruct': {'date': '2006-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Symptomatic Hypoglycemia', 'timeFrame': 'up to 5 days', 'description': 'symptomatic hypoglycemia (glucose \\< 55 mg/dL)during treatment period'}], 'primaryOutcomes': [{'measure': 'Hypoglycemic Events', 'timeFrame': 'up to 5 days', 'description': 'hypoglycemic events'}], 'secondaryOutcomes': [{'measure': 'Favorable 3 Month Modified Rankin', 'timeFrame': '3 months', 'description': '3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stroke', 'acute ischemic stroke', 'hyperglycemia', 'glucose', 'insulin', 'insulin and potassium therapy', 'GIK'], 'conditions': ['Stroke', 'Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the feasibility, safety and preliminary efficacy of the use of insulin infusions as treatment for hyperglycemic acute ischemic stroke patients.', 'detailedDescription': 'Ischemic stroke is a common, devastating and costly disease. Half of acute stroke patients have elevated glucose levels upon admission to the hospital, and hyperglycemia is associated with poor outcome for post-stroke patients. It is unclear if treatment of hyperglycemia or glucose lowering improves outcome, however, in animal stroke models and other human conditions, aggressive glucose lowering is beneficial.\n\nThe goal of this multicenter trial is to determine if tight control of blood glucose is beneficial in hyperglycemic patients with acute ischemic stroke. In the trial, researchers will compare intravenous (IV) glucose insulin and potassium (GIK) therapy plus meal insulin to control therapy in 72 stroke patients.\n\nParticipants will be randomly assigned to one of three groups-(1) the control group with a target glucose level of \\<300mg/dL; (2) the tight control GIK plus meal insulin group with a target of \\<110mg/dL; or (3) the loose control GIK plus meal insulin group with a target of \\<200mg/dL-with all groups avoiding glucose levels of \\<70mg/dL.\n\nThe specific aims of this study are to collect preliminary data on the safety and feasibility of GIK for treatment of hyperglycemia in acute stroke patients, and to collect preliminary data comparing tight GIK therapy with loose GIK therapy and control therapy. Information learned in this study will compliment ongoing work and allow for maximum efficiency in the design of future treatment trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older.\n* Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more major vessels.\n* Must arrive at hospital and be able to begin treatment within 2 hours of established eligibility and this must be within 24 hours of symptom onset. - - Patients unable to report symptom onset time or those awakening with symptoms must use the time last known to be well as the onset time.\n* Admission plasma glucose of \\> 110 mg/dL.\n\nExclusion Criteria:\n\n* Renal dysfunction as defined by a serum creatinine of \\>/=2.5 mg/dL at enrollment.\n* Substantial pre-existing neurological or psychiatric illness that would confound neurological assessment.\n* Patients who have received experimental therapy for the enrollment stroke.\n* Pregnant females.\n* Patients with other severe life threatening conditions that makes them unlikely to survive 90 days.\n* Patients who are unable to follow the protocol or come back for 90-day followup.\n* Patient has condition for which insulin infusion is the usual practice or the treating physician feels that there is an indication for insulin infusion.'}, 'identificationModule': {'nctId': 'NCT00282867', 'briefTitle': 'Glucose Regulation in Acute Stroke Patients (GRASP) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Glucose Regulation in Acute Stroke Patients (GRASP) Study', 'orgStudyIdInfo': {'id': '11901'}, 'secondaryIdInfos': [{'id': 'R01NS050192', 'link': 'https://reporter.nih.gov/quickSearch/R01NS050192', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tight control group', 'description': 'target glucose level 70-110 mg/dL', 'interventionNames': ['Drug: IV glucose insulin and potassium, GIK']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'loose control group', 'description': 'target glucose level 70 - 200 mg/dL', 'interventionNames': ['Drug: IV glucose insulin and potassium, GIK']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'usual care group', 'description': 'target level 70 - 300 mg/dL', 'interventionNames': ['Other: standard care']}], 'interventions': [{'name': 'IV glucose insulin and potassium, GIK', 'type': 'DRUG', 'description': 'The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.', 'armGroupLabels': ['loose control group', 'tight control group']}, {'name': 'standard care', 'type': 'OTHER', 'description': 'usual care', 'armGroupLabels': ['usual care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Karen Johnston, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia, Department of Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Karen C. Johnston, MD, MSc, PI, Professor and Chair Department of Neurology', 'oldOrganization': 'University of Virginia'}}}}