Clinical trial NCT05222659: Perioperative Glucose and Insulin Changes in Major Urologic Surgeries
Official title: Perioperative Glucose and Insulin Changes in Major Urologic Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urologic Diseases
Surgery
Blood Glucose, High
Keywords: surgery, blood glucose, continuous glucose monitoring
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults undergoing major urologic surgery at KUMC

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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine the perioperative glycemic changes longitudinally in patients undergoing major urologic surgeries.
timeFrame: Perioperatively up to post-operative day 4
Secondary outcomes:
measure: To determine the effect of perioperative insulin levels on glycemic variations in patients undergoing major urologic surgeries.
timeFrame: Perioperatively up to post-operative day 4
measure: To determine the effect of perioperative insulin, C-peptide, and Free-Fatty Acid (FFA)
timeFrame: Perioperatively up to post-operative day 4
measure: To determine the effect of perioperative insulin, C-peptide, and Free-Fatty Acid (FFA)
timeFrame: Perioperatively up to post-operative day 4
Other outcomes:
measure: To determine gastric emptying time of a carbohydrate drink.
timeFrame: at least 2 days before surgery
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jill Hamilton-Reeves, PhD
role: PRINCIPAL_INVESTIGATOR
References: