Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia
Information source: McGill University Health Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Cancer
Intervention: Travasol (amino acid injection) (Dietary Supplement); Insulin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: McGill University Health Center Official(s) and/or principal investigator(s):
Thomas Schricker, MD, Principal Investigator, Affiliation: McGill University Health Center
Overall contact:
Thomas Schricker, MD, Phone: 514-934-1934, Ext: 34884, Email: thomas.schricker@mcgill.ca
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.
Clinical Details
Official title: Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Net protein balance
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Thomas Schricker, MD, Phone: 514-934-1934, Ext: 34884, Email: thomas.schricker@mcgill.ca
McGill University Health Centre (MUHC) - Royal Victoria Hospital, Montreal, Quebec H8A1A1, Canada; Recruiting
Thomas Schricker, MD, Phone: 514-934-1934, Ext: 34884, Email: thomas.schricker@mcgill.ca
Thomas Shricker, MD, Principal Investigator
Ralph Lattermann, MD, Sub-Investigator
Sarkis Meterissian, MD, Sub-Investigator
Linda Wykes, PhD., Sub-Investigator
Additional Information
Related 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.
Starting date: December 2013
Last updated: January 9, 2014
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