Perioperative Glucose and Insulin Changes in Major Urologic Surgeries

Surgery Clinical Trial

— PEGLINS  

Official title:

Perioperative Glucose and Insulin Changes in Major Urologic Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05222659
• Other study ID #: STUDY00147628
• Status: Completed
• Start date: April 15, 2022
• Est. completion date: January 5, 2023

Study information

• Verified date: May 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 5, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Glucose, High
• Surgery
• Urologic Diseases

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	at least 2 days before surgery
Primary	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	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	Perioperatively up to post-operative day 4
Secondary	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	Perioperatively up to post-operative day 4
Secondary	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	Perioperatively up to post-operative day 4