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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)

Overall Status

Unknown status

CT.gov ID

NCT02032953

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

Enrollment

Location

Arms

100

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Dietary Supplement: Travasol (amino acid injection) Drug: Insulin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2013

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insulin, Travasol (35%) postop 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, .	Dietary Supplement: Travasol (amino acid injection) an amino acid supplementation infused intravenously containing essential and non-essential amino acids Other Names: Travasol 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. Other Names: HNC Hyperinsulinemic-normoglycemic clamp
Experimental: Insulin, Travasol (20%) postop 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.	Dietary Supplement: Travasol (amino acid injection) an amino acid supplementation infused intravenously containing essential and non-essential amino acids Other Names: Travasol 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. Other Names: HNC Hyperinsulinemic-normoglycemic clamp
Placebo Comparator: Insulin, no protein after surgery 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.	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. Other Names: HNC Hyperinsulinemic-normoglycemic clamp

Arm

Intervention/Treatment

Experimental: Insulin, Travasol (35%) postop

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, .

Dietary Supplement: Travasol (amino acid injection)

an amino acid supplementation infused intravenously containing essential and non-essential amino acids

Other Names:

Travasol

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.

Other Names:

HNC

Hyperinsulinemic-normoglycemic clamp

Experimental: Insulin, Travasol (20%) postop

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.

Dietary Supplement: Travasol (amino acid injection)

an amino acid supplementation infused intravenously containing essential and non-essential amino acids

Other Names:

Travasol

Drug: Insulin

Other Names:

HNC

Hyperinsulinemic-normoglycemic clamp

Placebo Comparator: Insulin, no protein after surgery

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.

Drug: Insulin

Other Names:

HNC

Hyperinsulinemic-normoglycemic clamp

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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