Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients

NCT ID: NCT04079660

Last Updated: 2021-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgical patients

Diabetic patients scheduled to undergo non-cardiac surgery

Capillary blood glucose blood draw

Intervention Type DIAGNOSTIC_TEST

Capillary blood glucose (CBG), HbA1c, fructosamine, albumin, BUN, and creatinine values will be obtained from a blood draw as a standard of care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CBG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female patients able to consent.
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

1. Inability to read, understand or sign the consent form
2. End-stage renal disease
3. Special populations (Incarcerated individuals, pregnant female patients)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Barbara Rogers

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26927745 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20435798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29135663 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29440113 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25458090 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25591856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28096825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25353659 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27777100 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1642452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29854962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29222377 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018H0320

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.