Dipeptide Alanyl Glutamine and Postoperative Insulin Resistance in Colon Carcinoma Patients

NCT00922688 | Unknown

• 1 other identifier: AIRCo05.02.2009/2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Dipeptide Alanyl-Glutamine; Insulin sensitivity; Intracellular signaling; Antioxidant/oxidant parameters; Lipolysis; Inflammatory response in the liver

Outcome Measures

Primary Outcomes (1)

• 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.

  Before and 1 day after surgery

Secondary Outcomes (7)

• The effect of the dipeptide alanyl-glutamine on components of the insulin signalling cascade in muscle tissue.

  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.

  Before and 1 day after surgery

• The effect of the dipeptide alanyl-glutamine on the amino acid concentration in muscle tissue.

  Before and 1 day after surgery

• The effect of the dipeptide alanyl-glutamine on antioxidant/oxidant parameters in the circulating compartment.

  Before and 1 day after surgery

• The effect of dipeptide alanyl-glutamine on the inflammatory response in the liver

  During surgery

Study Arms (3)

Dipeptiven Arm Enteral

ACTIVE COMPARATOR

Drug: Dipeptide Alanyl-Glutamine

Placebo Arm Enteral and Intravenously

PLACEBO COMPARATOR

Drug: Placebo

Dipeptiven ARM Intravenously

ACTIVE COMPARATOR

Drug: Dipeptide Alanyl-Glutamine

Interventions

Dipeptide Alanyl-Glutamine 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.

Dipeptiven ARM Intravenously

Placebo DRUG

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

Placebo Arm Enteral and Intravenously

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years
• Colon cancer patients scheduled for elective open abdominal surgery
• Capable of giving informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Center Alkmaar: lead

Study Sites (1)

Medical Center Alkmaar

Alkmaar, North Holland, 1815 JD, Netherlands

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Insulin Resistance

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alexander PJ Houdijk, MD,PhD

  MCA Alkmaar

  STUDY DIRECTOR

Central Study Contacts

Hamit Cakir, MD

CONTACT

0031725484444; h.cakir@mca.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: July 21, 2011

Record last verified: 2010-11

Locations

NL (1)