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

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)

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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