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Coronary Artery Bypass Graft SurgeryPreopNCT00618592

Does Pre-operative Carbohydrate Loading Reduce Insulin Resistance and Improve Outcomes in Elective Surgical Patients?

A study testing PreOp carbohydrate drink in people with Coronary Artery Bypass Graft Surgery and Spine Surgery, run by Unity Health Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The recent development of an oral carbohydrate drink for consumption prior to elective surgical procedures has been shown to improve insulin sensitivity. However, these studies have not investigated the use of this carbohydrate supplement in patients undergoing cardiac and spinal surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PreOp carbohydrate drink
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
Feb 2008to Aug 2009
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients undergoing elective coronary artery bypass graft or spinal (decompression and fusion) surgery
  • Ability to provide informed consent

Who cannot join

  • Patients undergoing associated cardiac procedures such as valve replacement or valve repair
  • Patients undergoing spinal surgery without fusion
  • Conditions likely to impair gastrointestinal motility or enhance gastrointestinal reflux
  • On medications likely to delay gastric emptying
  • BMI > 40
  • Existing Type I or Type II diabetes
  • Participated in another study in the past 30 days
  • Entering surgery greater than five hours after ingestion of morning drink

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

The recent development of an oral carbohydrate drink for consumption prior to elective surgical procedures has been shown to improve insulin sensitivity. However, these studies have not investigated the use of this carbohydrate supplement in patients undergoing cardiac and spinal surgery.

Hypothesis: The administration of 100g of carbohydrates the evening before and 50g of carbohydrates two hours before elective coronary artery bypass graft (CABG) or spinal surgery will reduce postoperative insulin resistance by 40% compared to those undergoing the standard of care of fasting the evening before and the day of surgery.

Read the detailed description

In many Western hospitals, including St. Michael's Hospital, fasting for 12-14 hours is the standard protocol for patients entering elective surgery. Fasting results in a depletion of energy stores and consequently, a patient enters surgery in a catabolic state. Furthermore, the human body reacts to surgery by producing a variety of stress hormones and other hormone-like proteins that enable the body to react to stress or injury appropriately. One of the changes that occurs with surgery is related to how the body stores and metabolizes glucose. During and after surgery, muscle and adipose tissue become less sensitive to the action of insulin (insulin resistant). Insulin resistance results in a reduced uptake of glucose by these tissues and subsequently to a rise in circulating blood glucose levels. Sustained high levels of blood glucose have been associated with post-surgical complications and less favourable outcomes. Previous studies have found that fasting before surgery exacerbates insulin resistance during and after surgery. The recent development of a carbohydrate drink for consumption prior to elective surgical procedures has been shown to be well tolerated and pose no additional risk of pulmonary aspiration when ingested two hours prior to surgery. Furthermore, there appears to be metabolic, psychological and possibly clinical benefits in pre-operative carbohydrate loading compared to fasting, including improvements in insulin resistance. However, the studies done to date have been limited by their small sample size, their lack of clinical outcome data and their reliance upon predominantly surgeries of shorter duration and reduced metabolic stress where insulin resistance is lower. Therefore, there is a need to investigate the effect of carbohydrate loading on insulin resistance and clinical outcomes in patients undergoing surgery of extended duration and complexity.

Patients undergoing major cardiac and spinal surgery are ideal for studying the effects of pre-operative carbohydrate loading since this type of operation is of long duration and relatively high surgical stress resulting in the development of significant insulin resistance, and thus potentially benefit from pre-operative carbohydrate loading. Therefore, we will be conducting a larger randomized trial investigating the effects of pre-operative carbohydrate loading in comparison with fasting on insulin resistance and clinical outcomes in patients undergoing invasive cardiac and spinal surgery at St. Michael's Hospital.

We hypothesize that consumption of a pre-operative carbohydrate load will reduce postoperative insulin resistance by 40% (measured by the standardized short insulin tolerance test). As secondary outcomes, we hypothesize that pre-operative carbohydrate loading will reduce circulating markers of inflammation and stress as well as improve clinical outcomes such as blood product utilization, incidence of hyperglycemia, rates of adverse events and length of stay in comparison with standard pre-operative fasting. This study will provide important information regarding the clinical benefits associated with the consumption of a pre-operative carbohydrate load. Many European centres have already liberalized their pre-operative treatments; this study will help to optimize the perioperative management and outcomes of surgical patients at our institution.

Being tested
PreOp carbohydrate drink
Keywords
carbohydrate supplementation, cardiac surgery, spine surgery, insulin resistance, insulin sensitivity, short insulin tolerance test, HOMA, outcomes
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PreOp carbohydrate drinkDietary supplement

    Also called PreOp, Nutricia

    800 mL of PreOp evening before surgery, 400 mL at least two hours before surgery

Study groups in NCT00618592
Study groupRoleWhat they receive
CHOExperimentalNot described
Receives: Dietary Supplement: PreOp carbohydrate drink
FASTNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insulin sensitivity

    Measured: baseline and postoperatively

Secondary outcomes (5)
  1. Markers of inflammation e.g., CRP, IL-6, free fatty acids

    Measured: baseline, in ICU, and 24, 48 and 72 hours postoperatively

  2. Glucose metabolism e.g., insulin-mediated glucose uptake and GLUT 4 translocation

    Measured: onset of surgery

  3. Clinical outcomes e.g., length of stay in ICU and hospital, blood transfusions

    Measured: during surgery and postoperatively

  4. Preoperative patient discomfort

    Measured: baseline and preoperatively

  5. IGF-1

    Measured: baseline, in ICU and 24, 48 and 72 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00618592
Sponsor's protocol ID
REB 02-117
Acronym
Preop
Status last verified
Feb 2009
First submitted
8 Feb 2008
Last updated
22 Jul 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Tran S, Wolever TM, Errett LE, Ahn H, Mazer CD, Keith M. Preoperative carbohydrate loading in patients undergoing coronary artery bypass or spinal surgery. Anesth Analg. 2013 Aug;117(2):305-13. doi: 10.1213/ANE.0b013e318295e8d1. Epub 2013 Jun 11.

    PubMed 23757474

Questions about this trial

What is this clinical trial studying?

A study testing PreOp carbohydrate drink in people with Coronary Artery Bypass Graft Surgery and Spine Surgery, run by Unity Health Toronto at 1 site in Canada.

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 2 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: finished, as of the sponsor's last update on 22 Jul 2010. 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 Canada. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin sensitivity (time frame: baseline and postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00618592, which also lists 1 linked publication.

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 22 Jul 2010.

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