Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglyc… (NCT02032953) | Clinical Trial Compass
UnknownPhase 4
Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia
Canada24 participantsStarted 2013-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Net protein balance
Timeframe: 6 hours after surgery
Trial details
NCT IDNCT02032953
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre