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CompletedNCT05222659PEGLINSUpdated May 15, 2023

Perioperative Glucose and Insulin Changes in Major Urologic Surgeries

An observational study in Urologic Diseases, Surgery and Blood Glucose, High, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-15.

Sponsored by University of Kansas Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Urologic Diseases
  • Surgery
  • Blood Glucose, High

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Keywords

  • surgery, blood glucose, continuous glucose monitoring
03

In context

Urologic Diseases

193 studies on the registry are indexed under Urologic Diseases; 51 are open to participants now.

This study's enrollment of 20 is below the median of 200 across 49 observational studies indexed under Urologic Diseases.

Browse Urologic Diseases studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adults undergoing major urologic surgery at KUMC

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Urologic surgery patients
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What researchers measure

Primary outcomes

  1. To determine the perioperative glycemic changes longitudinally in patients undergoing major urologic surgeries.

    Interstitial blood glucose levels measured by Continuous Glucose Monitor (CGM) device, in mg/dL

    Time frame: Perioperatively up to post-operative day 4

Secondary outcomes

  1. To determine the effect of perioperative insulin levels on glycemic variations in patients undergoing major urologic surgeries.

    Serum insulin in uIU/mL will be measured from participant blood samples

    Time frame: Perioperatively up to post-operative day 4

  2. To determine the effect of perioperative insulin, C-peptide, and Free-Fatty Acid (FFA)

    C-peptide in ng/mL will be measured from participant blood samples

    Time frame: Perioperatively up to post-operative day 4

  3. To determine the effect of perioperative insulin, C-peptide, and Free-Fatty Acid (FFA)

    FFA in mmol/L will be measured from participant blood samples

    Time frame: Perioperatively up to post-operative day 4

Other outcomes

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

    A specialized carbohydrate beverage will be given to a subset of willing participants in order to establish a feasible interval for consumption before surgery

    Time frame: at least 2 days before surgery

07

Study locations

1 site
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05222659
Lead sponsor
University of Kansas Medical Center
Responsible party
Jill Hamilton-Reeves, PhD RD LD (Associate Professor, University of Kansas Medical Center) — Principal investigator
First posted
Feb 3, 2022
Start date
Apr 15, 2022
Primary completion
Jan 5, 2023
Completion
Jan 5, 2023
Last update
May 15, 2023

Study contacts

Jill Hamilton-Reeves, PhD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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