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Mechanistic Prehabilitation

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ClinicalTrials.gov Identifier: NCT01919541
Recruitment Status : Withdrawn (difficulty in recruiting patients)
First Posted : August 9, 2013
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
The investigators hypothesize that individuals who receive a personalized 4 week prehabilitation program consisting of exercise and nutrition counselling with post-workout whey protein supplementation will show, before colorectal surgery, improved insulin sensitivity, inflammatory profile, and substrate utilization compared to baseline measures. These results will translate into a higher functional capacity before surgery as demonstrated by an improvement in 6-minute walking test.

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

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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

Arm Intervention/treatment
Prehabilitation
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.
Other: Prehabilitation
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
Other: Prehabilitation
All patients will receive nutrition guidance and a nutrition component with whey protein supplementation.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for elective colorectal surgery for cancer
  • 65 years and older

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) health status class 4-5
  • disabling co-morbid physical and mental conditions (e.g. orthopedic and neuromuscular disease, dementia, psychosis)
  • endocrine disorders (diabetes or hemoglobin A1C>6, hyper and hypothyrodisim)
  • steroid consumption
  • cardiac failure (New York Heart Association classes I-IV)
  • chronic obstructive pulmonary disease
  • renal failure (creatinine > 115µmol/l)
  • hepatic failure (liver aminotranferases >50% the normal range)
  • morbid obesity (BMI >40)
  • anemia (hematocrit < 30 %, haemoglobin <100 g/L, albumin < 25 g/L)
  • poor comprehension of English or French

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Franco Carli
Investigators
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Principal Investigator: Franco Carli, MD McGill University Health Centre/Research Institute of the McGill University Health Centre

Additional Information:
Publications:
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Responsible Party: Franco Carli, Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT01919541    
Other Study ID Numbers: 13-127-GEN
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: September 2015
Keywords provided by Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Colorectal Surgery
Additional relevant MeSH terms:
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Rectal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases