Carbohydrate Loading and Diabetes in Colorectal Surgery

In Individuals With Diabetes Undergoing Elective Colorectal Surgery, Is Carbohydrate Loading Preoperatively Safe? A Pilot Randomized Controlled Trial

The goal of this study is to evaluate the feasibility of conducting a large study that would assess the safety of carbohydrate drinks (i.e. juice) prior to elective colorectal surgery in patients with type 2 diabetes.

Traditionally, prior to surgeries involving a general anesthetic, patients have been told not to eat or drink anything after midnight due to the risk of aspiration. More recent research have shown that it is safe to have clear fluids up to 2 hours before an operation and this is reflected in the current anesthesia clinical guidelines. Moreover, it has been shown that subjecting patients to a state of starvation causes stress on the body that may lead to complications such as poor wound healing, infections, and delayed return to bowel function. A sugar drink before surgery has been shown to be beneficial and can lead to decreased complication rates and decreased length of stay after surgery.

However, it is currently not known if it is safe for patients with type 2 diabetes to have a sugar drink before their surgery since they have trouble processing sugars and a subset of patients with diabetes are at increased risk of aspiration due to delayed stomach emptying.

This feasibility study is designed to answer the question of whether a large scale trial can be conducted examining the benefits of a pre-operative sugar drink in patients with type 2 diabetes.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2; Surgery; Surgery--Complications
• Intervention / Treatment: Dietary supplement: Pre-operative carbohydrate drink

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All adult (>=18 years of age) patients with an established diagnosis of type 2 diabetes mellitus undergoing elective colorectal surgery at the University of Alberta Hospital, the Grey Nuns Hospital, the Royal Alexandra Hospital or the Misericordia Hospital will be eligible. Only patients treated with diet or oral hypoglycemic agents will be included.

Exclusion Criteria:

• Subjects <18 years of age, and those on insulin therapy preoperatively will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; Standard care for patients with diabetes pre-operatively .
Experimental: Carbohydrate drink; Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery	Dietary supplement: Pre-operative carbohydrate drink; Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference of preoperative glucose between the two groups	Examined in a non-inferiority fashion with NI margin set as 2mmol/L	Pre-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite outcome of diabetes-related complications	hypoglycemia, DKA, cancellation of surgery, ketosis or perioperative aspiration	Within 30 days of surgery or to discharge
length of stay	How long the patient stays in hospital after surgery in days	Within 30 days of surgery or to discharge
Surgical site infection	Whether a wound infection is noted in hospital	Within 30 days of surgery or to discharge
Postoperative complications using the Clavien Dindo scale	A composite measure of post-operative complications stratified based on the Clavien Dindo scale from 1-5 with increasing severity from 1 to 5.	Within 30 days of surgery or to discharge
Post-operative serum blood glucose concentration	Serum blood glucose compiled on a daily basis	Within 30 days of surgery or to discharge
Rate of peri-operative insulin use	Whether insulin or an insulin infusion in the peri-operative period is used	Within 30 days of surgery or to discharge

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Carbs Drink in Colorectal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No