Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-26 @ 3:32 PM
Study NCT ID:
NCT05222659
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2022-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Glucose and Insulin Changes in Major Urologic Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014570', 'term': 'Urologic Diseases'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'whole blood and serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-12', 'studyFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2022-02-01', 'lastUpdatePostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To determine gastric emptying time of a carbohydrate drink.', 'timeFrame': 'at least 2 days before surgery', 'description': 'A specialized carbohydrate beverage will be given to a subset of willing participants in order to establish a feasible interval for consumption before surgery'}], 'primaryOutcomes': [{'measure': 'To determine the perioperative glycemic changes longitudinally in patients undergoing major urologic surgeries.', 'timeFrame': 'Perioperatively up to post-operative day 4', 'description': 'Interstitial blood glucose levels measured by Continuous Glucose Monitor (CGM) device, in mg/dL'}], 'secondaryOutcomes': [{'measure': 'To determine the effect of perioperative insulin levels on glycemic variations in patients undergoing major urologic surgeries.', 'timeFrame': 'Perioperatively up to post-operative day 4', 'description': 'Serum insulin in uIU/mL will be measured from participant blood samples'}, {'measure': 'To determine the effect of perioperative insulin, C-peptide, and Free-Fatty Acid (FFA)', 'timeFrame': 'Perioperatively up to post-operative day 4', 'description': 'C-peptide in ng/mL will be measured from participant blood samples'}, {'measure': 'To determine the effect of perioperative insulin, C-peptide, and Free-Fatty Acid (FFA)', 'timeFrame': 'Perioperatively up to post-operative day 4', 'description': 'FFA in mmol/L will be measured from participant blood samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgery, blood glucose, continuous glucose monitoring'], 'conditions': ['Urologic Diseases', 'Surgery', 'Blood Glucose, High']}, 'descriptionModule': {'briefSummary': 'Urological surgery patients will have their blood glucose measured before, during, and after surgery. Blood glucose will be measured using a continuous glucose monitor (CGM) device. We hypothesize the presence of a hyperglycemic state towards the end of surgery due to increased metabolic demand.', 'detailedDescription': 'Surgical stress causes acute insulin resistance, increased circulating free-fatty acids, and reduced blood glucose uptake resulting in hyperglycemia. Intraoperative and postoperative glucose levels are typically only monitored in the diabetic or cardiac surgical patient. There is a lack of data on perioperative glucose levels in most prolonged surgeries and thus a barrier in determining the best glycemic management strategy to prevent or resolve acute insulin resistance and hyperglycemia. Obtaining blood glucose by CGM is less invasive and will avert disruption of current surgical pathways and standards of care while also producing reliable glucose measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults undergoing major urologic surgery at KUMC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥18 years) undergoing a major urologic surgery (proposed case duration \\>4 hours) at The University of Kansas Medical Center (KUMC)\n* English speaking\n\nExclusion Criteria:\n\n* Diagnosis of Type 1 or Type 2 diabetes mellitus or an A1C \\> 6.5%\n* Pregnant or lactating\n* Known allergy to milk, soy, egg, wheat, peanuts, or tree nuts\n* Swallowing difficulties'}, 'identificationModule': {'nctId': 'NCT05222659', 'acronym': 'PEGLINS', 'briefTitle': 'Perioperative Glucose and Insulin Changes in Major Urologic Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Perioperative Glucose and Insulin Changes in Major Urologic Surgeries', 'orgStudyIdInfo': {'id': 'STUDY00147628'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Urologic surgery patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Jill Hamilton-Reeves, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jill Hamilton-Reeves, PhD RD LD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}