Colon CarcinomaAIRCoNCT00922688
Dipeptide Alanyl Glutamine and Postoperative Insulin Resistance in Colon Carcinoma Patients
A study testing Dipeptide Alanyl-Glutamine in people with Colon Carcinoma, run by Medical Center Alkmaar at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Colon Carcinoma
- What is being tested?
- Dipeptide Alanyl-Glutamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2010to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Colon cancer patients scheduled for elective open abdominal surgery
- Capable of giving informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Medical Center Alkmaar
Alkmaar, North Holland, 1815 JD
Hamit Cakir, MD, 0031725484444, h.cakir@mca.nl
Alexander PJ Houdijk, MD, PhD
About this study
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.
Read more
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
- Being tested
- Dipeptide Alanyl-Glutamine, Placebo
- Keywords
- Dipeptide Alanyl-Glutamine, Insulin sensitivity, Intracellular signaling, Antioxidant/oxidant parameters, Lipolysis, Inflammatory response in the liver
- Medical subject headings
- Colonic Neoplasms, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dipeptide Alanyl-GlutamineDrug
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.
PlaceboDrug
Intravenous and enteral supplementation of placebo is started 24 hours prior to surgery and continued 24 hours postoperatively.
Dipeptide Alanyl-GlutamineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dipeptiven Arm Enteral | Active comparator | Not described Receives: Drug: Dipeptide Alanyl-Glutamine |
| Placebo Arm Enteral and Intravenously | Placebo comparator | Not described Receives: Drug: Placebo |
| Dipeptiven ARM Intravenously | Active comparator | Not described Receives: Drug: Dipeptide Alanyl-Glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Before and 1 day after surgery
The effect of the dipeptide alanyl-glutamine on the amino acid concentration in muscle tissue.
Measured: Before and 1 day after surgery
The effect of the dipeptide alanyl-glutamine on antioxidant/oxidant parameters in the circulating compartment.
Measured: Before and 1 day after surgery
The effect of dipeptide alanyl-glutamine on the inflammatory response in the liver
Measured: During surgery
The effect of dipeptide alanyl-glutamine on lipolysis.
Measured: Before and 1 day after surgery
The effect of dipeptide alanyl-glutamine on key enzymes involved in glucose production.
Measured: Before and 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startDec 2010
- Primary completionDec 2012 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Center Alkmaar
- Sponsor type
- University, hospital or other
- Investigators
- Alexander PJ Houdijk, MD,PhD, Study director, MCA Alkmaar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922688
- Sponsor's protocol ID
- AIRCo05.02.2009/2
- Acronym
- AIRCo
- Status last verified
- Nov 2010
- First submitted
- 16 Jun 2009
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dipeptide Alanyl Glutamine and Postoperative Insulin Resistance in Colon Carcinoma Patients
- ClinicalTrials.gov ID
- NCT00922688
- Acronym / sponsor ID
- AIRCo / AIRCo05.02.2009/2
- Conditions
- Colon Carcinoma
- Keywords
- Dipeptide Alanyl-Glutamine, Insulin sensitivity, Intracellular signaling, Antioxidant/oxidant parameters, Lipolysis, Inflammatory response in the liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical Center AlkmaarUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 75 years
- Colon cancer patients scheduled for elective open abdominal surgery
- Capable of giving informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dipeptide Alanyl-GlutamineIntravenous 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. | Drug | Dipeptiven ARM Intravenously |
| PlaceboIntravenous and enteral supplementation of placebo is started 24 hours prior to surgery and continued 24 hours postoperatively. | Drug | Placebo Arm Enteral and Intravenously |
| Dipeptide Alanyl-GlutamineEnteral 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. | Drug | Dipeptiven Arm Enteral |
Primary outcome
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
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander PJ Houdijk, MD,PhD study director
MCA Alkmaar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dipeptide Alanyl-Glutamine in people with Colon Carcinoma, run by Medical Center Alkmaar at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamit Cakir, MD (0031725484444, h.cakir@mca.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2011.