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

NCT02032953 | Unknown Phase 4

• 1 other identifier: 12-459-GEN
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; protein recovery; perioperative nutrition; hyperinsulinemia; normoglycemia; hyperinsulinemic-normoglycemic clamp; anabolism

Outcome Measures

Primary Outcomes (1)

• Net protein balance

  The difference in total body protein after randomization to one of the three treatment arms.

  6 hours after surgery

Study Arms (3)

Insulin, Travasol (35%) postop

EXPERIMENTAL

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); Drug: Insulin

Insulin, Travasol (20%) postop

EXPERIMENTAL

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); Drug: Insulin

Insulin, no protein after surgery

PLACEBO COMPARATOR

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

Interventions

Travasol (amino acid injection) DIETARY_SUPPLEMENT

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

Also known as: Travasol

Insulin, Travasol (20%) postop; Insulin, Travasol (35%) postop

Insulin DRUG

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.

Also known as: HNC, Hyperinsulinemic-normoglycemic clamp

Insulin, Travasol (20%) postop; Insulin, Travasol (35%) postop; Insulin, no protein after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

McGill University Health Centre (MUHC) - Royal Victoria Hospital

Montreal, Quebec, H8A1A1, Canada

Location

Related Publications (3)

• 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.

  PMID: 15492576 BACKGROUND

• 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.

  PMID: 10950834 RESULT

• Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.

  PMID: 37526194 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Hyperinsulinism

Interventions

amino-acid, glucose, and electrolyte solution; Amino Acids; Insulin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides

Study Officials

• Thomas Schricker, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Anesthesia

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 10, 2014
• Study Start: December 1, 2013
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

CA (1)