Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-07 @ 5:02 AM
Study NCT ID:
NCT04079660
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2019-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2019-09-03', 'studyFirstSubmitQcDate': '2019-09-03', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fasting capillary blood glucose level', 'timeFrame': '1 hour', 'description': 'Association between pre-operative HbA1c and fructosamine with pre-operative, fasting capillary blood glucose level measured the morning of surgery in preoperative holding area.'}], 'secondaryOutcomes': [{'measure': 'hypoglycemia', 'timeFrame': '1 day', 'description': 'i. Incidence of hypoglycemia, defined as CBG \\< 70 mg/dL, during the perioperative period'}, {'measure': 'hyperglycemia', 'timeFrame': '1 day', 'description': 'ii. Incidence of hyperglycemia, defined as CBG \\> 180 mg/dL, during the perioperative period'}, {'measure': 'infection', 'timeFrame': '1 day', 'description': 'Incidence of wound infection'}, {'measure': 'wound healing', 'timeFrame': '1 day', 'description': 'Incidence of poor wound healing'}, {'measure': 'delirium', 'timeFrame': '1 day', 'description': 'Incidence of post-operative delirium'}, {'measure': 'reoperation', 'timeFrame': '1 day', 'description': 'Incidence of reoperation procedure'}, {'measure': 'LOS', 'timeFrame': '1 day', 'description': 'Length of PACU stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemoglobinA1c', 'serum fructosamine', 'glycemic control'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '26927745', 'type': 'BACKGROUND', 'citation': 'Miller JD, Richman DC. Preoperative Evaluation of Patients with Diabetes Mellitus. Anesthesiol Clin. 2016 Mar;34(1):155-69. doi: 10.1016/j.anclin.2015.10.008.'}, {'pmid': '20435798', 'type': 'BACKGROUND', 'citation': 'Frisch A, Chandra P, Smiley D, Peng L, Rizzo M, Gatcliffe C, Hudson M, Mendoza J, Johnson R, Lin E, Umpierrez GE. Prevalence and clinical outcome of hyperglycemia in the perioperative period in noncardiac surgery. Diabetes Care. 2010 Aug;33(8):1783-8. doi: 10.2337/dc10-0304. Epub 2010 Apr 30.'}, {'pmid': '29135663', 'type': 'BACKGROUND', 'citation': 'Shohat N, Tarabichi M, Tischler EH, Jabbour S, Parvizi J. Serum Fructosamine: A Simple and Inexpensive Test for Assessing Preoperative Glycemic Control. J Bone Joint Surg Am. 2017 Nov 15;99(22):1900-1907. doi: 10.2106/JBJS.17.00075.'}, {'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.'}, {'pmid': '25458090', 'type': 'BACKGROUND', 'citation': 'Maradit Kremers H, Lewallen LW, Mabry TM, Berry DJ, Berbari EF, Osmon DR. Diabetes mellitus, hyperglycemia, hemoglobin A1C and the risk of prosthetic joint infections in total hip and knee arthroplasty. J Arthroplasty. 2015 Mar;30(3):439-43. doi: 10.1016/j.arth.2014.10.009. Epub 2014 Oct 15.'}, {'pmid': '25591856', 'type': 'BACKGROUND', 'citation': 'Danese E, Montagnana M, Nouvenne A, Lippi G. Advantages and pitfalls of fructosamine and glycated albumin in the diagnosis and treatment of diabetes. J Diabetes Sci Technol. 2015 Mar;9(2):169-76. doi: 10.1177/1932296814567227. Epub 2015 Jan 14.'}, {'pmid': '28096825', 'type': 'BACKGROUND', 'citation': 'Kowalczuk-Wieteska AM, Wrobel M, Rokicka D, Szymborska-Kajanek A, Foremny J, Nadziakiewicz P, Zembala M, Strojek K. Determination of the value of glycated hemoglobin HbA1c and fructosamine in assessing the risk of perioperative complications after cardiac surgery in patients with type 2 diabetes. Kardiochir Torakochirurgia Pol. 2016 Dec;13(4):305-308. doi: 10.5114/kitp.2016.64869. Epub 2016 Dec 30.'}, {'pmid': '25353659', 'type': 'BACKGROUND', 'citation': 'Malmstrom H, Walldius G, Grill V, Jungner I, Gudbjornsdottir S, Hammar N. Fructosamine is a useful indicator of hyperglycaemia and glucose control in clinical and epidemiological studies--cross-sectional and longitudinal experience from the AMORIS cohort. PLoS One. 2014 Oct 29;9(10):e111463. doi: 10.1371/journal.pone.0111463. eCollection 2014.'}, {'pmid': '27777100', 'type': 'BACKGROUND', 'citation': 'Rodriguez-Segade S, Rodriguez J, Camina F. Corrected Fructosamine improves both correlation with HbA1C and diagnostic performance. Clin Biochem. 2017 Feb;50(3):110-115. doi: 10.1016/j.clinbiochem.2016.10.014. Epub 2016 Oct 21.'}, {'pmid': '1642452', 'type': 'BACKGROUND', 'citation': 'Constanti C, Simo JM, Joven J, Camps J. Serum fructosamine concentration in patients with nephrotic syndrome and with cirrhosis of the liver: the influence of hypoalbuminaemia and hypergammaglobulinaemia. Ann Clin Biochem. 1992 Jul;29 ( Pt 4):437-42. doi: 10.1177/000456329202900412.'}, {'pmid': '29854962', 'type': 'BACKGROUND', 'citation': 'Gan T, Liu X, Xu G. Glycated Albumin Versus HbA1c in the Evaluation of Glycemic Control in Patients With Diabetes and CKD. Kidney Int Rep. 2017 Nov 21;3(3):542-554. doi: 10.1016/j.ekir.2017.11.009. eCollection 2018 May.'}, {'pmid': '29222377', 'type': 'BACKGROUND', 'citation': 'American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S55-S64. doi: 10.2337/dc18-S006.'}]}, 'descriptionModule': {'briefSummary': 'Diabetes mellitus is associated with negative outcomes in patients undergoing surgery. Blood sugar levels are monitored by measuring a values that include but are not limited to hemoglobin A1c, capillary blood glucose, and fructosamine . This study is being done to investigate if there is an associated between these values and postsurgical outcomes.', 'detailedDescription': 'This study aims to compare the predictive capacity of both fructosamine and HbA1c on preoperative basal glucose level, as well as adverse events (cardiovascular events, surgical site infection, and mortality) and length of post-anesthesia care unit (PACU) stay in both Type I and Type II diabetic patients. Secondary outcomes include length of anesthesia administration, an indicator of intraoperative complications, and perioperative glucose level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic patients sover 18 years of age, scheduled to undergo surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients able to consent.\n2. Patients with either Type I or Type II diabetes mellitus (DM)\n3. Patients undergoing non-cardiac surgeries under general anesthesia\n4. ≥ 18 years of age\n\nExclusion Criteria:\n\n1. Inability to read, understand or sign the consent form\n2. End-stage renal disease\n3. Special populations (Incarcerated individuals, pregnant female patients)'}, 'identificationModule': {'nctId': 'NCT04079660', 'briefTitle': 'Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Prospective, Observational Study Evaluating the Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients Undergoing Surgeries', 'orgStudyIdInfo': {'id': '2018H0320'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical patients', 'description': 'Diabetic patients scheduled to undergo non-cardiac surgery', 'interventionNames': ['Diagnostic Test: Capillary blood glucose blood draw']}], 'interventions': [{'name': 'Capillary blood glucose blood draw', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['CBG'], 'description': 'Capillary blood glucose (CBG), HbA1c, fructosamine, albumin, BUN, and creatinine values will be obtained from a blood draw as a standard of care', 'armGroupLabels': ['Surgical patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Barbara Rogers', 'investigatorAffiliation': 'Ohio State University'}}}}