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

NCT00618592 | Completed DMC

• 1 other identifier: REB 02-117
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass Graft Surgery; Spine Surgery

Keywords

carbohydrate supplementation; cardiac surgery; spine surgery; insulin resistance; insulin sensitivity; short insulin tolerance test; HOMA; outcomes

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  baseline and postoperatively

Secondary Outcomes (5)

• Markers of inflammation e.g., CRP, IL-6, free fatty acids

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

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

  onset of surgery

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

  during surgery and postoperatively

• Preoperative patient discomfort

  baseline and preoperatively

• IGF-1

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

Study Arms (2)

CHO

EXPERIMENTAL

Dietary Supplement: PreOp carbohydrate drink

FAST

NO INTERVENTION

Interventions

PreOp carbohydrate drink DIETARY_SUPPLEMENT

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

Also known as: PreOp, Nutricia

CHO

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

• 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.

  PMID: 23757474 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• C. David Mazer, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 20, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 22, 2010

Record last verified: 2009-02

Locations

CA (1)