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OpenTrials
Completed

NCT Number: NCT04079660

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Capillary blood glucose blood draw

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

Other names: CBG

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2019
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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