Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients
NCT ID: NCT04079660
Last Updated: 2021-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2021-02-01
2021-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Surgical patients
Diabetic patients scheduled to undergo non-cardiac surgery
Capillary blood glucose blood draw
Capillary blood glucose (CBG), HbA1c, fructosamine, albumin, BUN, and creatinine values will be obtained from a blood draw as a standard of care
Interventions
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Capillary blood glucose blood draw
Capillary blood glucose (CBG), HbA1c, fructosamine, albumin, BUN, and creatinine values will be obtained from a blood draw as a standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with either Type I or Type II diabetes mellitus (DM)
3. Patients undergoing non-cardiac surgeries under general anesthesia
4. ≥ 18 years of age
Exclusion Criteria
2. End-stage renal disease
3. Special populations (Incarcerated individuals, pregnant female patients)
18 Years
ALL
No
Sponsors
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Ohio State University
OTHER
Responsible Party
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Barbara Rogers
Associate Professor
Locations
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The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2018H0320
Identifier Type: -
Identifier Source: org_study_id
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