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

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ClinicalTrials.gov Identifier: NCT04079660
Recruitment Status : Active, not recruiting
First Posted : September 5, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Barbara Rogers, Ohio State University

Brief 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 . This study is being done to investigate if there is an associated between these values and postsurgical outcomes.

Condition or disease Intervention/treatment
Diabetes Diagnostic Test: Capillary blood glucose blood draw

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective, Observational Study Evaluating the Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients Undergoing Surgeries
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Group/Cohort Intervention/treatment
Surgical patients
Diabetic patients scheduled to undergo non-cardiac surgery
Diagnostic Test: 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 Name: CBG




Primary Outcome Measures :
  1. fasting capillary blood glucose level [ Time Frame: 1 hour ]
    Association between pre-operative HbA1c and fructosamine with pre-operative, fasting capillary blood glucose level measured the morning of surgery in preoperative holding area.


Secondary Outcome Measures :
  1. hypoglycemia [ Time Frame: 1 day ]
    i. Incidence of hypoglycemia, defined as CBG < 70 mg/dL, during the perioperative period

  2. hyperglycemia [ Time Frame: 1 day ]
    ii. Incidence of hyperglycemia, defined as CBG > 180 mg/dL, during the perioperative period

  3. infection [ Time Frame: 1 day ]
    Incidence of wound infection

  4. wound healing [ Time Frame: 1 day ]
    Incidence of poor wound healing

  5. delirium [ Time Frame: 1 day ]
    Incidence of post-operative delirium

  6. reoperation [ Time Frame: 1 day ]
    Incidence of reoperation procedure

  7. LOS [ Time Frame: 1 day ]
    Length of PACU stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Diabetic patients sover 18 years of age, scheduled to undergo surgery
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04079660


Locations
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United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University

Publications:

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Responsible Party: Barbara Rogers, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT04079660     History of Changes
Other Study ID Numbers: 2018H0320
First Posted: September 5, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barbara Rogers, Ohio State University:
hemoglobinA1c
serum fructosamine
glycemic control