|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01919541|
Recruitment Status : Withdrawn (difficulty in recruiting patients)
First Posted : August 9, 2013
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Rectal Cancer||Other: Prehabilitation Device: hyperinsulinemic euglycemic isoaminoacid clamp Device: hyperinsulinemic euglycemic hyperaminoacid clamp Dietary Supplement: whey protein supplementation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Understanding How Exercise and Nutrition Enhance Preoperative Functional Capacity: a Mechanistic Study|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
All patients will receive a prehabilitation program involving an individualized exercise and nutrition program 4 weeks before surgery. Whole body protein kinetics and insulin resistance will be determined at the beginning of the program and at the end of the program.
All patients will receive a prehabilitation program, which involves a personalized exercise component provided by a kinesiologist.
Device: hyperinsulinemic euglycemic isoaminoacid clamp
A hyperinsulinemic euglycemic isoaminoacid clamp followed by a hyperinsulinemic euglycemic hyperaminoacid clamp performed at baseline and immediately before surgery will provide insight into insulin resistance of glucose and protein metabolism in colorectal cancer patients pre- and post-intervention. Similarly, simultaneous infusions of leucine and glucose stable isotopes will provide insight into baseline and interventional effects of the program on whole body leucine and glucose kinetics.
Device: hyperinsulinemic euglycemic hyperaminoacid clamp
Dietary Supplement: whey protein supplementation
All patients will receive nutrition guidance and a nutrition component with whey protein supplementation.
- Protein Synthesis [ Time Frame: up to 4 weeks before surgery ]The change in whole body protein synthesis, measured using stable isotope technology, from baseline to date of surgery, will be documented, in response to hyperinsulinemia with the use of a hyperinsulinemic euglycemic hyperaminoacidemic clamp.
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): NCT01919541
|Montreal General Hospital|
|Montreal, Quebec, Canada, H3G 1A4|
|Principal Investigator:||Franco Carli, MD||McGill University Health Centre/Research Institute of the McGill University Health Centre|