Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia

Colorectal Cancer Clinical Trial

Official title:

Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02032953
• Other study ID #: 12-459-GEN
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 2013
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists class<3

• age>18 years

• colorectal surgery for non-metastatic colorectal adenocarcinoma including right and left hemicolectomy, transverse, subtotal and total colectomy sigmoid and low anterior resection

• ability to give informed consent

Exclusion Criteria:

• BMI>30 Kg/meter squared

• confirmed diagnosis of diabetes mellitus or a HbA1c>6.0%

• significant cardiorespiratory, hepatic, renal and neurological disease

• musculoskeletal or neuromuscular disease

• ingestion of drugs known to affect protein, glucose and lipid metabolism (e.g. steroids)

• severe anemia (hemoglobin<10 g/dL

• pregnancy

• history of severe sciatica, back surgery or other conditions which contraindicate the use of epidural catheters

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• Travasol (amino acid injection)
an amino acid supplementation infused intravenously containing essential and non-essential amino acids

Drug:
• Insulin
After the insertion of an arterial catheter and obtaining a baseline arterial blood glucose value, 2 units of insluin will be administered iv followed by an infusion of 2 microunits/kg*min. Ten minuts after starting the insulin, and when the the blood glucose is<6 mmol/L, dextrose 20% supplemented with phosphate (30mmol/L) will be infused. Blood glucose levels measured every 15 minutes and the dextrose infusion rate adjusted to maintain arterial glycemia between 4 and 6 mmol/L until end of study.

Locations

Country	Name	City	State
Canada	McGill University Health Centre (MUHC) - Royal Victoria Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Schricker T, Meterissian S, Wykes L, Eberhart L, Lattermann R, Carli F. Postoperative protein sparing with epidural analgesia and hypocaloric dextrose. Ann Surg. 2004 Nov;240(5):916-21. doi: 10.1097/01.sla.0000143249.93856.66. — View Citation

Schricker T, Wykes L, Carli F. Epidural blockade improves substrate utilization after surgery. Am J Physiol Endocrinol Metab. 2000 Sep;279(3):E646-53. doi: 10.1152/ajpendo.2000.279.3.E646. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net protein balance	The difference in total body protein after randomization to one of the three treatment arms.	6 hours after surgery