Does Pre-operative Carbohydrate Loading Reduce Insulin Resistance and Improve Outcomes in Elective Surgical Patients? (Preop)
Primary Purpose
Coronary Artery Bypass Graft Surgery, Spine Surgery
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PreOp carbohydrate drink
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Bypass Graft Surgery focused on measuring carbohydrate supplementation, cardiac surgery, spine surgery, insulin resistance, insulin sensitivity, short insulin tolerance test, HOMA, outcomes
Eligibility Criteria
Inclusion Criteria:
- Adult patients undergoing elective coronary artery bypass graft or spinal (decompression and fusion) surgery
- Ability to provide informed consent
Exclusion Criteria:
- 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
Sites / Locations
- St. Michael's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CHO
FAST
Arm Description
Outcomes
Primary Outcome Measures
Insulin sensitivity
Secondary Outcome Measures
Markers of inflammation e.g., CRP, IL-6, free fatty acids
Glucose metabolism e.g., insulin-mediated glucose uptake and GLUT 4 translocation
Clinical outcomes e.g., length of stay in ICU and hospital, blood transfusions
Preoperative patient discomfort
IGF-1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00618592
Brief Title
Does Pre-operative Carbohydrate Loading Reduce Insulin Resistance and Improve Outcomes in Elective Surgical Patients?
Acronym
Preop
Official Title
Does Pre-operative Carbohydrate Loading Reduce Insulin Resistance and Improve Outcomes in Elective Surgical Patients?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Unity Health Toronto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Graft Surgery, Spine Surgery
Keywords
carbohydrate supplementation, cardiac surgery, spine surgery, insulin resistance, insulin sensitivity, short insulin tolerance test, HOMA, outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CHO
Arm Type
Experimental
Arm Title
FAST
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
PreOp carbohydrate drink
Other Intervention Name(s)
PreOp, Nutricia
Intervention Description
800 mL of PreOp evening before surgery, 400 mL at least two hours before surgery
Primary Outcome Measure Information:
Title
Insulin sensitivity
Time Frame
baseline and postoperatively
Secondary Outcome Measure Information:
Title
Markers of inflammation e.g., CRP, IL-6, free fatty acids
Time Frame
baseline, in ICU, and 24, 48 and 72 hours postoperatively
Title
Glucose metabolism e.g., insulin-mediated glucose uptake and GLUT 4 translocation
Time Frame
onset of surgery
Title
Clinical outcomes e.g., length of stay in ICU and hospital, blood transfusions
Time Frame
during surgery and postoperatively
Title
Preoperative patient discomfort
Time Frame
baseline and preoperatively
Title
IGF-1
Time Frame
baseline, in ICU and 24, 48 and 72 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients undergoing elective coronary artery bypass graft or spinal (decompression and fusion) surgery
Ability to provide informed consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. David Mazer, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
23757474
Citation
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.
Results Reference
derived
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Does Pre-operative Carbohydrate Loading Reduce Insulin Resistance and Improve Outcomes in Elective Surgical Patients?
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