Perioperative Glucose and Insulin Changes in Major Urologic Surgeries
PEGLINS
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2022
CompletedFirst Posted
Study publicly available on registry
February 3, 2022
CompletedStudy Start
First participant enrolled
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2023
CompletedMay 15, 2023
May 1, 2023
9 months
January 13, 2022
May 12, 2023
Conditions
Keywords
Outcome Measures
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
Perioperatively up to post-operative day 4
Secondary Outcomes (3)
To determine the effect of perioperative insulin levels on glycemic variations in patients undergoing major urologic surgeries.
Perioperatively up to post-operative day 4
To determine the effect of perioperative insulin, C-peptide, and Free-Fatty Acid (FFA)
Perioperatively up to post-operative day 4
To determine the effect of perioperative insulin, C-peptide, and Free-Fatty Acid (FFA)
Perioperatively up to post-operative day 4
Other Outcomes (1)
To determine gastric emptying time of a carbohydrate drink.
at least 2 days before surgery
Study Arms (1)
Urologic surgery patients
Eligibility Criteria
Adults undergoing major urologic surgery at KUMC
You may qualify if:
- Adult (≥18 years) undergoing a major urologic surgery (proposed case duration \>4 hours) at The University of Kansas Medical Center (KUMC)
- English speaking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Biospecimen
whole blood and serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jill Hamilton-Reeves, PhD
University of Kansas Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 13, 2022
First Posted
February 3, 2022
Study Start
April 15, 2022
Primary Completion
January 5, 2023
Study Completion
January 5, 2023
Last Updated
May 15, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share