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WithdrawnNCT02032953Updated Oct 8, 2026

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

A Phase 4 interventional study of Travasol (amino acid injection) and Insulin in Colorectal Cancer, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 4, Interventional, and Treatment

Why this study was withdrawn
organisational problems
Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • colorectal cancer
  • protein recovery
  • perioperative nutrition
  • hyperinsulinemia
  • normoglycemia
  • hyperinsulinemic-normoglycemic clamp
  • anabolism
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

Browse Colorectal Neoplasms studies →

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 420 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
0 participants (actual)

Study arms

  • 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) · Drug: Insulin

  • 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) · Drug: Insulin

  • 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

Interventions

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

    Also known as: Travasol

  • 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

06

What researchers measure

Primary outcomes

  1. Net protein balance

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

    Time frame: 6 hours after surgery

07

Study locations

1 site
  • McGill University Health Centre (MUHC) - Royal Victoria Hospital
    Montreal, Quebec H8A1A1, Canada
08

References and documents

Publications

  • 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. PubMed 15492576 ↗
  • 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. PubMed 10950834 ↗
  • 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. PubMed 37526194 ↗
09

Timeline

1 registry update since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2013, a primary completion of Apr 2024 and a completion of Apr 2024. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2014
First posted
Jan 10, 2014
Start
Dec 2013
Primary completionActual
Apr 2024
CompletionActual
Apr 2024
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT02032953
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Thomas Schricker (Chief of Anesthesia, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted
Jan 10, 2014
Start date
Dec 2013
Primary completion
Apr 2024
Completion
Apr 2024
Last update
Oct 8, 2026

Study contacts

Thomas Schricker, MD
principal investigator · McGill University Health Centre/Research Institute of the McGill University Health Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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