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

Phase 4

Active, not recruiting

• Conditions: Colorectal Cancer
• Interventions: Dietary Supplement: Travasol (amino acid injection); Drug: Insulin

• Registration Number: NCT02032953
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-17
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin, Travasol (35%) postop	Travasol (amino acid injection)	Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid supplementation) given from start of surgery to 6 hours after, at an amount of 35% of patient's energy expenditure as measured before surgery, .
Insulin, Travasol (20%) postop	Travasol (amino acid injection)	Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid infusion), given from start of surgery to 6 hours after, at an amount of 20% of patient's energy expenditure as measured before surgery.
Insulin, Travasol (20%) postop	Insulin	Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid infusion), given from start of surgery to 6 hours after, at an amount of 20% of patient's energy expenditure as measured before surgery.
Insulin, no protein after surgery	Insulin	Insulin (hyperinsulinemic-normoglycemic clamp, an insulin infusion between 2 and 5 microunits/kg with glucose at a variable rated titrated to maintain normoglycemia, blood glucose 4-6 mmol/L) with no protein supplementation from start of surgery to 6 hours after.
Insulin, Travasol (35%) postop	Insulin	Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid supplementation) given from start of surgery to 6 hours after, at an amount of 35% of patient's energy expenditure as measured before surgery, .

Primary Outcome Measures

Name	Time	Method
Net protein balance	6 hours after surgery	The difference in total body protein after randomization to one of the three treatment arms.

Trial Locations

Locations (1)

McGill University Health Centre (MUHC) - Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada