Dipeptide Alanyl Glutamine and Postoperative Insulin Resistance in Colon Carcinoma Patients

NCT ID: NCT00922688

Last Updated: 2011-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-05-31

Brief Summary

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.

Conditions

Colon Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Dipeptiven Arm Enteral

Group Type: ACTIVE_COMPARATOR

Dipeptide Alanyl-Glutamine

Intervention Type: DRUG

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 Arm Enteral and Intravenously

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous and enteral supplementation of placebo is started 24 hours prior to surgery and continued 24 hours postoperatively.

Dipeptiven ARM Intravenously

Group Type: ACTIVE_COMPARATOR

Dipeptide Alanyl-Glutamine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Placebo

Intravenous and enteral supplementation of placebo is started 24 hours prior to surgery and continued 24 hours postoperatively.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical Center Alkmaar

OTHER

Sponsor Role: lead

Responsible Party

Medical Center Alkmaar

Principal Investigators

Alexander PJ Houdijk, MD,PhD

Role: STUDY_DIRECTOR

MCA Alkmaar

Locations

Medical Center Alkmaar

Alkmaar, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Hamit Cakir, MD

Role: CONTACT

h.cakir@mca.nl

0031725484444

Facility Contacts

Hamit Cakir, MD

Role: primary

h.cakir@mca.nl

0031725484444

Other Identifiers

AIRCo05.02.2009/2

Identifier Type: -

Identifier Source: org_study_id