Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
Study NCT ID:
NCT06589466
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-17
First Post:
2024-09-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Optimization of Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-21', 'size': 209847, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-05T16:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46000}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2024-09-05', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevelance of diabetes among surgical population', 'timeFrame': '11/2019-12/2023', 'description': 'Determine the incidence of diabetes in the surgical population'}, {'measure': 'HB1AC measuerment in diabetic patients', 'timeFrame': '11/2019-12/2023', 'description': 'Determine the incidence of valid HbA1C in diabetic patients presenting for surgery'}, {'measure': 'Long term diabetes control among surgical patients', 'timeFrame': '11/2019-12/2023', 'description': 'Determine long-term diabetes control through assessment of HbA1C values in diabetic patients presenting for surgery'}], 'secondaryOutcomes': [{'measure': 'In hospital mortality', 'timeFrame': '11/2019-12/2023', 'description': 'Determine association between HbA1C and in hospital mortality'}, {'measure': 'Post-operative length of stay', 'timeFrame': '11/2019-12/2023', 'description': 'Determine association between HbA1C and post-operative length of stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Surgery Related Complications Rate']}, 'referencesModule': {'references': [{'pmid': '16618895', 'type': 'BACKGROUND', 'citation': 'Dronge AS, Perkal MF, Kancir S, Concato J, Aslan M, Rosenthal RA. Long-term glycemic control and postoperative infectious complications. Arch Surg. 2006 Apr;141(4):375-80; discussion 380. doi: 10.1001/archsurg.141.4.375.'}, {'pmid': '28746706', 'type': 'BACKGROUND', 'citation': 'Jones CE, Graham LA, Morris MS, Richman JS, Hollis RH, Wahl TS, Copeland LA, Burns EA, Itani KMF, Hawn MT. Association Between Preoperative Hemoglobin A1c Levels, Postoperative Hyperglycemia, and Readmissions Following Gastrointestinal Surgery. JAMA Surg. 2017 Nov 1;152(11):1031-1038. doi: 10.1001/jamasurg.2017.2350.'}, {'pmid': '23636187', 'type': 'BACKGROUND', 'citation': 'Stryker LS, Abdel MP, Morrey ME, Morrow MM, Kor DJ, Morrey BF. Elevated postoperative blood glucose and preoperative hemoglobin A1C are associated with increased wound complications following total joint arthroplasty. J Bone Joint Surg Am. 2013 May 1;95(9):808-14, S1-2. doi: 10.2106/JBJS.L.00494.'}, {'pmid': '29440113', 'type': 'BACKGROUND', 'citation': 'van den Boom W, Schroeder RA, Manning MW, Setji TL, Fiestan GO, Dunson DB. Effect of A1C and Glucose on Postoperative Mortality in Noncardiac and Cardiac Surgeries. Diabetes Care. 2018 Apr;41(4):782-788. doi: 10.2337/dc17-2232. Epub 2018 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'Diabetic patients, as part of preoperative evaluation, should have glycated hemoglobin (HbA1C) measured. HbA1C provides information on longterm glucose control. There is a suggestion in the literature that elevated A1C levels predict a higher rate of postoperative adverse events, including infections, myocardial infarction, and mortality. It is unclear whether chronic glycemia, as reflected in raised HbA1C level, is the risk factor for adverse perioperative events or whether it is a surrogate measure for poor perioperative glucose management. Conversely, in a retrospective analysis of 431,480 surgeries perioperative glucose was predictive of increased 30-day mortality, but that HbA1C was a less useful predictor of this measure. In our experience of at the University of Alberta Preadmission Clinic there is significant variability with respect to whether diabetic patients have a valid HbA1C measurement i.e. within 3 months of surgery. If a valid measurement is present, there is also considerable variability with respect to diabetes control.', 'detailedDescription': 'Purpose: The purpose of this study to retrospectively determine the incidence of diabetes in the surgical population and what proportion of diabetic patients have a valid HbA1C. Hypothesis: A valid (measured within 3 months of surgery) HbA1C measurement is frequently missing prior to surgery and when present has a high chance of being higher than normal.\n\nObjectives:\n\nPerform a retrospective analysis of all surgeries in Alberta from November 2019 to the present time looking for the following:\n\nPrimary outcomes:\n\n1. Determine the incidence of diabetes in the surgical population and describe the demographics and clinical charcteristics of patients\n2. Determine the incidence of valid HbA1C in diabetic patients presenting for surgery\n3. Determine long-term diabetes control through assessment of HbA1C values in diabetic patients presenting for surgery\n\nSecondary outcomes:\n\n1. Determine association between HbA1C and post-operative length of stay\n2. Determine association between HbA1C and in hospital mortality Design: This study will be a population-based, retrospective observational cohort study. Setting: Alberta Hospitals Participants: Adults with diabetes having surgery in Alberta since November 2019 Descriptive statistics will be tabulated according to HbA1C status and Univariate comparisons of means, medians and proportions will be performed to evaluate the association of independent variables with primary and secondary outcomes. Normally distributed continuous data will be reported as means with standard deviations (SD). Non-normally distributed continuous data will be reported as medians with interquartile ranges (IQR). Categorical variables will be compared using Chi-square test for independence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Adults having any surgical procedure at any hospital in Alberta', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or greater\n* Having any surgical procedure at any hospital in Alberta\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT06589466', 'briefTitle': 'Preoperative Optimization of Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Retrospective Review of Preoperative Optimization of Diabetic Patients', 'orgStudyIdInfo': {'id': 'Pro00139994'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with diabetes having surgery in Alberta since November 2019', 'description': 'Adults with diabetes having surgery in Alberta since November 2019', 'interventionNames': ['Other: Surgery']}], 'interventions': [{'name': 'Surgery', 'type': 'OTHER', 'description': 'this study in observational study, no intervention.', 'armGroupLabels': ['Adults with diabetes having surgery in Alberta since November 2019']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G2R3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The study team still debating sharing the IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}