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DiabetesNCT04079660

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

An observational study of Diabetes, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes
What is being tested?
Capillary blood glucose blood draw
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Feb 2021to 1 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Diabetic patients sover 18 years of age, scheduled to undergo surgery

Who may be able to join

  • Male or female patients able to consent.
  • Patients with either Type I or Type II diabetes mellitus (DM)
  • Patients undergoing non-cardiac surgeries under general anesthesia
  • ≥ 18 years of age

Who cannot join

  • Inability to read, understand or sign the consent form
  • End-stage renal disease
  • Special populations (Incarcerated individuals, pregnant female patients)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Prospective, Observational Study Evaluating the Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients Undergoing Surgeries

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.

Read the detailed description

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
Diabetes
Being tested
Capillary blood glucose blood draw
Keywords
hemoglobinA1c, serum fructosamine, glycemic control
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capillary blood glucose blood drawDiagnostic test

    Also called CBG

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

Study groups in NCT04079660
Study groupRoleWhat they receive
Surgical patientsDiabetic patients scheduled to undergo non-cardiac surgery
Receives: Diagnostic Test: Capillary blood glucose blood draw

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fasting capillary blood glucose level

    Association between pre-operative HbA1c and fructosamine with pre-operative, fasting capillary blood glucose level measured the morning of surgery in preoperative holding area.

    Measured: 1 hour

Secondary outcomes (7)

  1. hypoglycemia

    1. Incidence of hypoglycemia, defined as CBG < 70 mg/dL, during the perioperative period

    Measured: 1 day

  2. hyperglycemia

    ii. Incidence of hyperglycemia, defined as CBG > 180 mg/dL, during the perioperative period

    Measured: 1 day

  3. infection

    Incidence of wound infection

    Measured: 1 day

  4. wound healing

    Incidence of poor wound healing

    Measured: 1 day

  5. delirium

    Incidence of post-operative delirium

    Measured: 1 day

  6. reoperation

    Incidence of reoperation procedure

    Measured: 1 day

  7. LOS

    Length of PACU stay

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start1 Feb 2021
  3. Primary completion1 Feb 2021
  4. Study completion1 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04079660
Sponsor's protocol ID
2018H0320
Status last verified
Sep 2021
First submitted
3 Sep 2019
Last updated
22 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared.

Publications

  • 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.

    PubMed 26927745

  • 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.

    PubMed 20435798

  • 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.

    PubMed 29135663

  • 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.

    PubMed 29440113

  • 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.

    PubMed 25458090

  • 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.

    PubMed 25591856

  • 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.

    PubMed 28096825

  • 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.

    PubMed 25353659

  • 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.

    PubMed 27777100

  • 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.

    PubMed 1642452

  • 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.

    PubMed 29854962

  • 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.

    PubMed 29222377

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fasting capillary blood glucose level (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04079660, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.

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