Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 1:38 AM
Study NCT ID:
NCT00585494
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
2007-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevalence of Inpatient Hyperglycemia: Risks, Complications and Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D048909', 'term': 'Diabetes Complications'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'asr@medicine.wisc.edu', 'phone': '608-335-6734', 'title': 'Ann Marie Sheehy, M.D., M.S.', 'organization': 'University of Wisconsin Madison'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Preoperative Orthopedic', 'description': 'Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevalence of Hyperglycemia in the Elective Orthopedic Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative Orthopedic', 'description': 'Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.'}], 'classes': [{'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Number of orthopedic patients that have elevated fasting blood glucose levels preoperatively', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prevalence of Undiagnosed Diabetes in the Elective Orthopedic Population.', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Prevalence of Adverse Outcomes in the Hyperglycemic Elective Orthopedic Population.', 'timeFrame': '1 year', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Preoperative Orthopedic', 'description': 'Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Preoperative Orthopedic', 'description': 'Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '197', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.5', 'spread': '1.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '168', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '134', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '302', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2007-12-27', 'resultsFirstSubmitDate': '2008-11-07', 'studyFirstSubmitQcDate': '2007-12-27', 'lastUpdatePostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-23', 'studyFirstPostDateStruct': {'date': '2008-01-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Hyperglycemia in the Elective Orthopedic Population', 'timeFrame': '1 year', 'description': 'Number of orthopedic patients that have elevated fasting blood glucose levels preoperatively'}], 'secondaryOutcomes': [{'measure': 'Prevalence of Undiagnosed Diabetes in the Elective Orthopedic Population.', 'timeFrame': '1 year'}, {'measure': 'Prevalence of Adverse Outcomes in the Hyperglycemic Elective Orthopedic Population.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Diabetes Complications']}, 'referencesModule': {'references': [{'pmid': '22887757', 'type': 'DERIVED', 'citation': 'Sheehy AM, Benca J, Glinberg SL, Li Z, Nautiyal A, Anderson PA, Squire MW, Coursin DB. Preoperative "NPO" as an opportunity for diabetes screening. J Hosp Med. 2012 Oct;7(8):611-6. doi: 10.1002/jhm.1958. Epub 2012 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'This protocol will determine the prevalence of hyperglycemia and diabetes in the elective orthopedic population at the University of Wisconsin. It will also determine if there is a difference in outcomes. The study hypothesizes that at least 10% of patients will have some degree of impaired glucose regulation that has previously been undiagnosed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'University of Wisconsin orthopedic clinic patients ages 18 and older', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 years or older\n* Undergoing elective total knee, hip or lumbar spinal surgery\n\nExclusion Criteria:\n\n* Pregnancy\n* Unable to give consent'}, 'identificationModule': {'nctId': 'NCT00585494', 'briefTitle': 'Prevalence of Inpatient Hyperglycemia: Risks, Complications and Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Prevalence of Inpatient Hyperglycemia: Risks, Complications and Outcomes', 'orgStudyIdInfo': {'id': 'M-2007-0199'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preoperative orthopedic', 'description': 'Patients undergoing elective total hip, knee and spinal surgery at University of Wisconsin hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Ann M Sheehy, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}