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Clinical Trials/NCT05222659
NCT05222659CompletedNot Applicable

Perioperative Glucose and Insulin Changes in Major Urologic Surgeries

University of Kansas Medical Center1 site in 1 country20 target enrollmentStarted: April 15, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
To determine the perioperative glycemic changes longitudinally in patients undergoing major urologic surgeries.

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • To determine the effect of perioperative insulin levels on glycemic variations in patients undergoing major urologic surgeries.(Perioperatively up to post-operative day 4)
  • To determine the effect of perioperative insulin, C-peptide, and Free-Fatty Acid (FFA)(Perioperatively up to post-operative day 4)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jill Hamilton-Reeves, PhD RD LD

Associate Professor

University of Kansas Medical Center

Study Sites (1)

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