Perioperative Glucose and Insulin Changes in Major Urologic Surgeries

Overview

Urological surgery patients will have their blood glucose measured before, during, and after surgery. Blood glucose will be measured using a continuous glucose monitor (CGM) device. We hypothesize the presence of a hyperglycemic state towards the end of surgery due to increased metabolic demand.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 5, 2023

Detailed Description

Surgical stress causes acute insulin resistance, increased circulating free-fatty acids, and reduced blood glucose uptake resulting in hyperglycemia. Intraoperative and postoperative glucose levels are typically only monitored in the diabetic or cardiac surgical patient. There is a lack of data on perioperative glucose levels in most prolonged surgeries and thus a barrier in determining the best glycemic management strategy to prevent or resolve acute insulin resistance and hyperglycemia. Obtaining blood glucose by CGM is less invasive and will avert disruption of current surgical pathways and standards of care while also producing reliable glucose measurements.

Arms, Groups and Cohorts

  • Urologic surgery patients

Clinical Trial Outcome Measures

Primary Measures

  • To determine the perioperative glycemic changes longitudinally in patients undergoing major urologic surgeries.
    • Time Frame: Perioperatively up to post-operative day 4
    • Interstitial blood glucose levels measured by Continuous Glucose Monitor (CGM) device, in mg/dL

Secondary Measures

  • To determine the effect of perioperative insulin levels on glycemic variations in patients undergoing major urologic surgeries.
    • Time Frame: Perioperatively up to post-operative day 4
    • Serum insulin in uIU/mL will be measured from participant blood samples
  • To determine the effect of perioperative insulin, C-peptide, and Free-Fatty Acid (FFA)
    • Time Frame: Perioperatively up to post-operative day 4
    • C-peptide in ng/mL will be measured from participant blood samples
  • To determine the effect of perioperative insulin, C-peptide, and Free-Fatty Acid (FFA)
    • Time Frame: Perioperatively up to post-operative day 4
    • FFA in mmol/L will be measured from participant blood samples

Participating in This Clinical Trial

Inclusion Criteria

  • Adult (≥18 years) undergoing a major urologic surgery (proposed case duration >4 hours) at The University of Kansas Medical Center (KUMC) – English speaking Exclusion Criteria:

  • Diagnosis of Type 1 or Type 2 diabetes mellitus or an A1C > 6.5% – Pregnant or lactating – Known allergy to milk, soy, egg, wheat, peanuts, or tree nuts – Swallowing difficulties

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Kansas Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jill Hamilton-Reeves, PhD RD LD, Associate Professor – University of Kansas Medical Center
  • Overall Official(s)
    • Jill Hamilton-Reeves, PhD, Principal Investigator, University of Kansas Medical Center

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