Dipeptide Alanyl Glutamine and Postoperative Insulin Resistance in Colon Carcinoma Patients (AIRCo)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Medical Center Alkmaar.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical Center Alkmaar
ClinicalTrials.gov Identifier:
NCT00922688
First received: June 16, 2009
Last updated: July 20, 2011
Last verified: November 2010
  Purpose

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 Intervention
Colon Carcinoma
Drug: Dipeptide Alanyl-Glutamine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Dipeptide Alanyl Glutamine and Postoperative Insulin Resistance in Colon Carcinoma Patients

Resource links provided by NLM:


Further study details as provided by Medical Center Alkmaar:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The effect of the dipeptide alanyl-glutamine on the amino acid concentration in muscle tissue. [ Time Frame: Before and 1 day after surgery ] [ Designated as safety issue: No ]
  • The effect of the dipeptide alanyl-glutamine on antioxidant/oxidant parameters in the circulating compartment. [ Time Frame: Before and 1 day after surgery ] [ Designated as safety issue: No ]
  • The effect of dipeptide alanyl-glutamine on the inflammatory response in the liver [ Time Frame: During surgery ] [ Designated as safety issue: No ]
  • The effect of dipeptide alanyl-glutamine on lipolysis. [ Time Frame: Before and 1 day after surgery ] [ Designated as safety issue: No ]
  • The effect of dipeptide alanyl-glutamine on key enzymes involved in glucose production. [ Time Frame: Before and 1 day after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Drug: Placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 75 years
  • 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
  • BMI above 30 kg/m2
  • Use of certain medication: thyroid medication, corticosteroids, diuretic medication
  • Known bleeding disorders or increased PTT and or APTT
  • Any medical condition except for colon cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922688

Contacts
Contact: Hamit Cakir, MD 0031725484444 h.cakir@mca.nl

Locations
Netherlands
Medical Center Alkmaar Recruiting
Alkmaar, Noord holland, Netherlands, 1815 JD
Contact: Hamit Cakir, MD    0031725484444    h.cakir@mca.nl   
Principal Investigator: Alexander PJ Houdijk, MD, PhD         
Sub-Investigator: Hamit Cakir, MD         
Sponsors and Collaborators
Medical Center Alkmaar
Investigators
Study Director: Alexander PJ Houdijk, MD,PhD MCA Alkmaar
  More Information

No publications provided

Responsible Party: H. Cakir, Medical Center Alkmaar
ClinicalTrials.gov Identifier: NCT00922688     History of Changes
Other Study ID Numbers: AIRCo05.02.2009/2
Study First Received: June 16, 2009
Last Updated: July 20, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Center Alkmaar:
Dipeptide Alanyl-Glutamine
Insulin sensitivity
Intracellular signaling
Antioxidant/oxidant parameters
Lipolysis
Inflammatory response in the liver

Additional relevant MeSH terms:
Carcinoma
Insulin Resistance
Colonic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014