Skip to main content
OpenTrials
Completed

NCT Number: NCT05222659

Perioperative Glucose and Insulin Changes in Major Urologic Surgeries

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urologic Diseases Blood Glucose, High Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Surgery Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

Other outcomes

  1. To determine gastric emptying time of a carbohydrate drink.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Acronym: PEGLINS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2022
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.