Urologic DiseasesPEGLINSNCT05222659
Perioperative Glucose and Insulin Changes in Major Urologic Surgeries
An observational study of Urologic Diseases and Surgery, run by University of Kansas Medical Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Diseases, Surgery, Blood Glucose, High
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2022to 5 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing major urologic surgery at KUMC
Who may be able to join
- Adult (≥18 years) undergoing a major urologic surgery (proposed case duration >4 hours) at The University of Kansas Medical Center (KUMC)
- English speaking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
- Conditions
- Urologic Diseases, Surgery, Blood Glucose, High
- Keywords
- surgery, blood glucose, continuous glucose monitoring
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Urologic surgery patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Serum insulin in uIU/mL will be measured from participant blood samples
Measured: Perioperatively up to post-operative day 4
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
Measured: Perioperatively up to post-operative day 4
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
Measured: Perioperatively up to post-operative day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start15 Apr 2022
- Primary completion5 Jan 2023
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center
- Investigators
- Jill Hamilton-Reeves, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222659
- Sponsor's protocol ID
- STUDY00147628
- Acronym
- PEGLINS
- Status last verified
- May 2023
- First submitted
- 13 Jan 2022
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Glucose and Insulin Changes in Major Urologic Surgeries
- ClinicalTrials.gov ID
- NCT05222659
- Acronym / sponsor ID
- PEGLINS / STUDY00147628
- Conditions
- Urologic Diseases, Surgery, Blood Glucose, High
- Keywords
- surgery, blood glucose, continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urologic surgery patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing major urologic surgery at KUMC
Key inclusion criteria (2 listed)
- Adult (≥18 years) undergoing a major urologic surgery (proposed case duration >4 hours) at The University of Kansas Medical Center (KUMC)
- English speaking
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
To determine the effect of perioperative insulin, C-peptide, and Free-Fatty Acid (FFA)
Time frame: Perioperatively up to post-operative day 4
To determine the effect of perioperative insulin, C-peptide, and Free-Fatty Acid (FFA)
Time frame: Perioperatively up to post-operative day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Hamilton-Reeves, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Diseases and Surgery, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the perioperative glycemic changes longitudinally in patients undergoing major urologic surgeries. (time frame: Perioperatively up to post-operative day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.