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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02032953
Enrollment
24
Registered
2014-01-10
Start date
2013-12-31
Completion date
2024-04-30
Last updated
2023-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTTravasol (amino acid injection)

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

DRUGInsulin

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.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Net protein balance6 hours after surgeryThe difference in total body protein after randomization to one of the three treatment arms.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026