The effect of the dipeptide alanyl-glutamine, intravenously or enterally and perioperatively given, on postoperative insulin resistance in colon cancer patients.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary objective is to reduce/prevent the postoperative insulin resistance
in colon cancer patients by the intravenous or enteral and perioperative
administration of the dipeptide alanyl-glutamine.
Secondary outcome
- The effect of the dipeptide alanyl-glutamine on intracellular signalling in
muscle tissue.
- The effect of the dipeptide alanyl-glutamine on glutathione concentration in
muscle tissue.
- The effect of the dipeptide alanyl-glutamine on the amino acid concentration
in muscle tissue.
- The effect of the dipeptide alanyl-glutamine on the inflammatory response in
the circulating compartment.
- The effect of the dipeptide alanyl-glutamine on antioxidant/oxidant
parameters in the circulating compartment.
- The effect of the dipeptide alanyl-glutamine on the inflammatory response in
liver tissue.
- The effect of the dipeptide alanyl-glutamine on the
inflammatory response in fat tissue.
Background summary
It is well known that insulin resistance occurs after mediocre and intensive
surgery, such as colon cancer surgery. Disturbances in insulin action
negatively affect the postoperative recovery, either by prolonging the capacity
of the body to regain normal function, or by increasing the metabolic stress
and the risk for complications. Several studies have shown that focusing
therapies on improving insulin resistance is successful. Experimental studies
have shown that antioxidant agents, like glutamine (a precursor of
glutathione), improve insulin sensitivity. The hypothesis of this study is that
perioperative parenteral or enteral administration of glutamine, given as the
dipeptide alanyl-glutamine, will reduce or prevent postoperative insulin
resistance in colon cancer patients.
Study objective
The effect of the dipeptide alanyl-glutamine, intravenously or enterally and
perioperatively given, on postoperative insulin resistance in colon cancer
patients.
Study design
A double blinded, placebo controlled, randomised, pilot study at the Surgery
Department of the Medical Center Alkmaar.
Intervention
Patients will receive glutamine intravenously or enterally, starting 24 hours
prior to surgery, until 24 hours after surgery in the dosage of 0.5 g/kg/day,
or receive a placebo, normal saline, for the same period of time in equal
amount.
Study burden and risks
Risks: Surgical site infection, bleeding and hematoma due to the biopsy
Burden: 2 periods of 7 hours for the clamp method
Wilhelminalaan 12
1815 JD Alkmaar
NL
Wilhelminalaan 12
1815 JD Alkmaar
NL
Listed location countries
Age
Inclusion criteria
- Age between 18 and 75 year
- Colon cancer patients scheduled for elective open abdominal surgery
- Capable of giving informed consent
Exclusion criteria
- Patients who are participating in another clinical trial
- Unable to receive oral intake
- Major malabsorption disorder of the gut
- Patients with diabetes mellitus
- Use of certain medication: thyroid medication, corticosteroids, diuretic medication
- BMI above 30 kg/m2
- Known bleeding disorders or increased PTT and/or APTT
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-007748-33-NL |
| CCMO | NL25981.094.08 |