Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-28 @ 8:47 AM
Study NCT ID:
NCT00753766
Status:
TERMINATED
Last Update Posted:
2019-02-11
First Post:
2008-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multifactorial Pre-operative Intervention in Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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': 'paul.conlin@va.gov', 'phone': '8572035111', 'title': 'Paul R. Conlin, M.D.', 'organization': 'VA Boston Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.', 'eventGroups': [{'id': 'EG000', 'title': 'Multifactorial Intervention', 'description': 'Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Control group', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Screened Participants That Are Eligible and Choose Participation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multifactorial Intervention', 'description': 'Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'unitOfMeasure': 'percentage of potential participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Full Adherence to the Study Protocol (i.e. Attending Study Visits, CGMS Studies)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multifactorial Intervention', 'description': 'Mulitfactorial intervention - addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.\n\nMultifactorial Intervention'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Not Completing the Protocol Due to the Need for Urgent Surgery and/or Treatment-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multifactorial Intervention', 'description': 'Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.'}, {'type': 'SECONDARY', 'title': 'Change in A1c From Baseline to Pre-admission (A1c is the Standard Parameter to Assess Chronic Glucose Control])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multifactorial Intervention', 'description': 'Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Control group'}], 'timeFrame': '6 weeks', 'description': 'A1c measured at two time points - baseline and 6 weeks later (pre-admission). This parameter is the difference between those two time points.', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and data for this parameter were not collected. There were -0- participants enrolled in the Usual Care group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Occurrence of Wound Infection in the 30 Day Post-operative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multifactorial Intervention', 'description': 'Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multifactorial Intervention', 'description': 'Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'unitOfMeasure': 'days', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experience a Composite of Death From Cardiovascular Cause, Non-fatal Myocardial Infarction, Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention, Nonfatal Stroke, or Amputation as a Result of Peripheral Ischemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multifactorial Intervention', 'description': 'Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Need to Return to the Operating Room', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multifactorial Intervention', 'description': 'Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Multifactorial Intervention', 'description': 'Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Control group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Multifactorial Intervention', 'description': 'Mulitfactorial intervention - addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Control group'}, {'id': 'BG002', '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': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and their data could not be analyzed. There were -0- participants enrolled in the Usual Care group.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Inadequate participant recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-05', 'studyFirstSubmitDate': '2008-09-12', 'resultsFirstSubmitDate': '2014-09-19', 'studyFirstSubmitQcDate': '2008-09-16', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-09-19', 'studyFirstPostDateStruct': {'date': '2008-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Screened Participants That Are Eligible and Choose Participation', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Full Adherence to the Study Protocol (i.e. Attending Study Visits, CGMS Studies)', 'timeFrame': '6 weeks'}, {'measure': 'Percentage of Participants Not Completing the Protocol Due to the Need for Urgent Surgery and/or Treatment-related Complications', 'timeFrame': '6 weeks'}, {'measure': 'Change in A1c From Baseline to Pre-admission (A1c is the Standard Parameter to Assess Chronic Glucose Control])', 'timeFrame': '6 weeks', 'description': 'A1c measured at two time points - baseline and 6 weeks later (pre-admission). This parameter is the difference between those two time points.'}, {'measure': 'Number of Participants With Occurrence of Wound Infection in the 30 Day Post-operative Period', 'timeFrame': '30 days'}, {'measure': 'Length of Hospital Stay', 'timeFrame': '6 weeks'}, {'measure': 'Number of Participants Who Experience a Composite of Death From Cardiovascular Cause, Non-fatal Myocardial Infarction, Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention, Nonfatal Stroke, or Amputation as a Result of Peripheral Ischemia', 'timeFrame': '6 weeks'}, {'measure': 'Percentage of Participants Who Need to Return to the Operating Room', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['A1c', 'Blood Glucose Management', 'Blood Pressure', 'Case Management', 'Diabetes Mellitus', 'Intervention study', 'Multifactorial', 'Peri-operative complications', 'Pre-operative'], 'conditions': ['Diabetes Mellitus', 'Surgical Procedure, Unspecified']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to advance the quality of care among inpatients with diabetes in the VHA. When patients with diabetes are admitted to the hospital, there is a greater chance that they will have a complication that lengthens their stay in the hospital. We are testing whether managing their diabetes before admission makes a difference in occurrence of in-hospital complications.', 'detailedDescription': 'Patients with diabetes that require hospitalization are at increased risk for morbidity and mortality, especially when undergoing surgery. There is some evidence that intensive glucose management during hospitalization may improve outcomes. However, no studies have evaluated intensive diabetes treatment before hospitalization.\n\nPreliminary data from patients having vascular surgery show that those with diabetes have longer hospital stays, more frequent wound infections, and are more likely to require a return to the operating room when compared to patients without diabetes. In particular, insulin-treated patients have even greater peri-operative complications than non-insulin treated patients with diabetes. However, these data also suggest that a clinical trial to test the hypothesis that pre-operative intensive management has significant impact on peri-operative complications would require a very large number of participants to have adequate power.\n\nThus, our objective is to conduct a pilot and feasibility study to determine whether an intervention that involves intensive pre-operative diabetes management can be successfully implemented and to assess whether trends for benefit are observed. The results of this trial will support the conduct of a definitive study that tests the effectiveness of such an intervention in a larger sample of patients.\n\nThis is a randomized, parallel group clinical trial in insulin-treated patients with diabetes mellitus who have been scheduled for elective vascular surgery. We will randomize 46 participants diabetes mellitus: insulin-treated with HbA1c 7.5% or treated with oral agents with an elevated HbA1c who are scheduled for vascular surgery and in whom a 6 week pre-operative delay poses no substantial medical risks, as determined by the staff surgeon. We will exclude individuals with markedly elevated HbA1c or blood pressure; those with recently manifest cardiovascular disease, and those unable to attend regularly scheduled follow-up visits during the pre-operative period.\n\nParticipants will be randomized to either continue with usual care or participate in a multifactorial intervention conducted over a 6-week period. During the intervention period, participants will meet with a care manager and/or endocrinologist on at least 3 occasions and have telephone follow-up between these visits. They will receive instruction on lifestyle modifications; measure glucose and blood pressure at home (including the use of a continuous glucose monitoring device on 2 occasions), and receive care management to optimize glucose, blood pressure, and lipid lowering, as appropriate.\n\nThe primary outcome measure is the percent of screened participants that are eligible and choose participation Secondary end points will include: participant adherence with the study protocol, change from baseline in A1c and fructosamine, occurrence of wound infections in the 30-day peri-operative period, a composite of death from cardiovascular causes, non-fatal myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, nonfatal stroke, or amputation as a result of peripheral ischemia; length of hospital stay; and rate of return to the operating room.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus\n* A1c 7.5%,\n* Scheduled elective vascular surgery that may be safely deferred for 6 weeks\n* Surgeon's approval to participate\n\nExclusion Criteria:\n\n* Hemoglobin A1c \\>14% (This criterion was included since, once identified, such a patient warrants improved glucose control and can not be ethically entered into a trial where there is a 50% chance of being assigned to usual care)\n* Myocardial infarction in prior 6 months\n* Cerebrovascular disease in prior 6 months\n* Active cancer requiring ongoing treatment\n* Severe psychiatric disease limiting ability to comply with protocol\n* Unable to attend follow up appointments"}, 'identificationModule': {'nctId': 'NCT00753766', 'briefTitle': 'Multifactorial Pre-operative Intervention in Diabetes Mellitus', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Multifactorial Pre-Operative Intervention in Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'CLIN-004-04F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multifactorial Intervention', 'description': 'Mulitfactorial intervention - addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.', 'interventionNames': ['Other: Multifactorial Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Control group'}], 'interventions': [{'name': 'Multifactorial Intervention', 'type': 'OTHER', 'armGroupLabels': ['Multifactorial Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Paul R. Conlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}