Perioperative Glucose and Insulin Changes in Major Urologic Surgeries

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05222659

Acronym

PEGLINS

Enrollment

Registered

2022-02-03

Start date

2022-04-15

Completion date

2023-01-05

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Glucose, High, Surgery, Urologic Diseases

Keywords

surgery, blood glucose, continuous glucose monitoring

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	C-peptide in ng/mL will be measured from participant blood samples

Other

Measure	Time frame	Description
To determine gastric emptying time of a carbohydrate drink.	at least 2 days before surgery	A specialized carbohydrate beverage will be given to a subset of willing participants in order to establish a feasible interval for consumption before surgery

Countries

United States

Outcome results