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

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McGill University

Status and phase

Active, not recruiting
Phase 4

Conditions

Colorectal Cancer

Treatments

Dietary Supplement: Travasol (amino acid injection)
Drug: Insulin

Study type

Interventional

Funder types

Other

Identifiers

NCT02032953
12-459-GEN

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 3 patient groups, including a placebo group

Insulin, Travasol (35%) postop
Experimental group
Description:
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, .
Treatment:
Drug: Insulin
Dietary Supplement: Travasol (amino acid injection)
Insulin, Travasol (20%) postop
Experimental group
Description:
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.
Treatment:
Drug: Insulin
Dietary Supplement: Travasol (amino acid injection)
Insulin, no protein after surgery
Placebo Comparator group
Description:
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.
Treatment:
Drug: Insulin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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