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

Primary Purpose

Colorectal Cancer

Status

Active

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Travasol (amino acid injection)

Insulin

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, protein recovery, perioperative nutrition, hyperinsulinemia, normoglycemia, hyperinsulinemic-normoglycemic clamp, anabolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

McGill University Health Centre (MUHC) - Royal Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Insulin, Travasol (35%) postop

Insulin, Travasol (20%) postop

Insulin, no protein after surgery

Arm 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, .

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.

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.

Outcomes

Primary Outcome Measures

Net protein balance

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02032953

First Posted

January 8, 2014

Last Updated

March 16, 2023

Sponsor

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

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT02032953

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 2013 (undefined)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Insulin, Travasol (35%) postop

Arm Type

Experimental

Arm Description

Arm Title

Insulin, Travasol (20%) postop

Arm Type

Experimental

Arm Description

Arm Title

Insulin, no protein after surgery

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Travasol (amino acid injection)

Other Intervention Name(s)

Travasol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Insulin

Other Intervention Name(s)

HNC, Hyperinsulinemic-normoglycemic clamp

Intervention Description

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.

Primary Outcome Measure Information:

Title

Net protein balance

Description

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

Time Frame

6 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Schricker, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

McGill University Health Centre (MUHC) - Royal Victoria Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H8A1A1

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

15492576

Citation

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.

Results Reference

background

PubMed Identifier

10950834

Citation

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.

Results Reference

result

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

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