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

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ClinicalTrials.gov Identifier: NCT02032953
Recruitment Status : Active, not recruiting
First Posted : January 10, 2014
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Thomas Schricker, 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2013
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Net protein balance [ Time Frame: 6 hours after surgery ]
    The difference in total body protein after randomization to one of the three treatment arms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032953


Locations
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Canada, Quebec
McGill University Health Centre (MUHC) - Royal Victoria Hospital
Montreal, Quebec, Canada, H8A1A1
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Thomas Schricker, MD McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications of Results:
Other Publications:
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Responsible Party: Thomas Schricker, Chief of Anesthesia, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02032953     History of Changes
Other Study ID Numbers: 12-459-GEN
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Thomas Schricker, McGill University Health Centre/Research Institute of the McGill University Health Centre:
colorectal cancer
protein recovery
perioperative nutrition
hyperinsulinemia
normoglycemia
hyperinsulinemic-normoglycemic clamp
anabolism
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Insulin
Insulin, Globin Zinc
Amino-acid, glucose, and electrolyte solution
Anabolic Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Parenteral Nutrition Solutions
Pharmaceutical Solutions