Perioperative Glucose and Insulin Changes in Major Urologic Surgeries

Completed

• Conditions: Urologic Diseases; Surgery; Blood Glucose, High

• Registration Number: NCT05222659
• Lead Sponsor: University of Kansas Medical Center

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 Timeline

• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-03
• Study Start: 2022-04-15
• Primary Completion: 2023-01-05
• Study Completion: 2023-01-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To determine the effect of perioperative insulin levels on glycemic variations in patients undergoing major urologic surgeries.	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)	Perioperatively up to post-operative day 4	FFA in mmol/L will be measured from participant blood samples

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States