Dipeptide Alanyl Glutamine and Postoperative Insulin Resistance in Colon Carcinoma Patients (AIRCo)
|ClinicalTrials.gov Identifier: NCT00922688|
Recruitment Status : Unknown
Verified November 2010 by Medical Center Alkmaar.
Recruitment status was: Recruiting
First Posted : June 17, 2009
Last Update Posted : July 21, 2011
Rationale: 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. The study will also be focused on the different routes of administration, because of the expected differential metabolic effects.
Objective: The investigators' primary objective is to study whether intravenous or enteral administration of the dipeptide alanyl-glutamine will reduce or prevent 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.
Study population: Thirty patients of male gender and any ethnicity, who will undergo elective open abdominal colon surgery for colon cancer, aged 18-75 years.
Intervention: Patients will receive dipeptide alanyl-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 saline (control group), for the same period of time.
Main study parameters/endpoints: The main study parameter is postoperative insulin resistance. Secondary study parameters are lipolysis, oxidative stress and glucoregulatory hormones. Muscle, liver and fat biopsies will be taken to study insulin sensitive as well as inflammatory pathways.
|Condition or disease||Intervention/treatment||Phase|
|Colon Carcinoma||Drug: Dipeptide Alanyl-Glutamine Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Dipeptide Alanyl Glutamine and Postoperative Insulin Resistance in Colon Carcinoma Patients|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||May 2013|
|Active Comparator: Dipeptiven Arm Enteral||
Drug: Dipeptide Alanyl-Glutamine
Enteral supplementation of the dipeptide alanyl-glutamine is started 24 hours prior to surgery (dosage glutamine: 0,5 g/kg/day, and continued 24 hours postoperatively.
|Placebo Comparator: Placebo Arm Enteral and Intravenously||
Intravenous and enteral supplementation of placebo is started 24 hours prior to surgery and continued 24 hours postoperatively.
|Active Comparator: Dipeptiven ARM Intravenously||
Drug: Dipeptide Alanyl-Glutamine
Intravenous supplementation of the dipeptide alanyl-glutamine is started 24 hours prior to surgery (dosage glutamine: 0,5 g/kg/day, and continued 24 hours postoperatively.
- The effect of intravenously and enterally administered dipeptide alanyl-glutamine preoperatively on postoperative insulin resistance in colon cancer patients.given, on postoperative insulin resistance in colon cancer patients. [ Time Frame: Before and 1 day after surgery ]
- The effect of the dipeptide alanyl-glutamine on components of the insulin signalling cascade in muscle tissue. [ Time Frame: Before and 1 day after surgery ]
- The effect of the dipeptide alanyl-glutamine on the systemic inflammatory response as well as on inflammatory pathways in muscle. [ Time Frame: Before and 1 day after surgery ]
- The effect of the dipeptide alanyl-glutamine on the amino acid concentration in muscle tissue. [ Time Frame: Before and 1 day after surgery ]
- The effect of the dipeptide alanyl-glutamine on antioxidant/oxidant parameters in the circulating compartment. [ Time Frame: Before and 1 day after surgery ]
- The effect of dipeptide alanyl-glutamine on the inflammatory response in the liver [ Time Frame: During surgery ]
- The effect of dipeptide alanyl-glutamine on lipolysis. [ Time Frame: Before and 1 day after surgery ]
- The effect of dipeptide alanyl-glutamine on key enzymes involved in glucose production. [ Time Frame: Before and 1 day after surgery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922688
|Contact: Hamit Cakir, MDfirstname.lastname@example.org|
|Medical Center Alkmaar||Recruiting|
|Alkmaar, Noord holland, Netherlands, 1815 JD|
|Contact: Hamit Cakir, MD 0031725484444 email@example.com|
|Principal Investigator: Alexander PJ Houdijk, MD, PhD|
|Sub-Investigator: Hamit Cakir, MD|
|Study Director:||Alexander PJ Houdijk, MD,PhD||MCA Alkmaar|