Carbohydrate Loading and Diabetes in Colorectal Surgery
Primary Purpose
Diabetes Mellitus, Type 2, Surgery, Surgery--Complications
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pre-operative carbohydrate drink
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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.
Sites / Locations
- University of Alberta Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Care
Carbohydrate drink
Arm Description
Standard care for patients with diabetes pre-operatively .
Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery
Outcomes
Primary Outcome Measures
Mean difference of preoperative glucose between the two groups
Examined in a non-inferiority fashion with NI margin set as 2mmol/L
Secondary Outcome Measures
Composite outcome of diabetes-related complications
hypoglycemia, DKA, cancellation of surgery, ketosis or perioperative aspiration
length of stay
How long the patient stays in hospital after surgery in days
Surgical site infection
Whether a wound infection is noted in hospital
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.
Post-operative serum blood glucose concentration
Serum blood glucose compiled on a daily basis
Rate of peri-operative insulin use
Whether insulin or an insulin infusion in the peri-operative period is used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04410419
Brief Title
Carbohydrate Loading and Diabetes in Colorectal Surgery
Official Title
In Individuals With Diabetes Undergoing Elective Colorectal Surgery, Is Carbohydrate Loading Preoperatively Safe? A Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Surgery, Surgery--Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard care for patients with diabetes pre-operatively .
Arm Title
Carbohydrate drink
Arm Type
Experimental
Arm Description
Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
Pre-operative carbohydrate drink
Intervention Description
Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery
Primary Outcome Measure Information:
Title
Mean difference of preoperative glucose between the two groups
Description
Examined in a non-inferiority fashion with NI margin set as 2mmol/L
Time Frame
Pre-operative
Secondary Outcome Measure Information:
Title
Composite outcome of diabetes-related complications
Description
hypoglycemia, DKA, cancellation of surgery, ketosis or perioperative aspiration
Time Frame
Within 30 days of surgery or to discharge
Title
length of stay
Description
How long the patient stays in hospital after surgery in days
Time Frame
Within 30 days of surgery or to discharge
Title
Surgical site infection
Description
Whether a wound infection is noted in hospital
Time Frame
Within 30 days of surgery or to discharge
Title
Postoperative complications using the Clavien Dindo scale
Description
A composite measure of post-operative complications stratified based on the Clavien Dindo scale from 1-5 with increasing severity from 1 to 5.
Time Frame
Within 30 days of surgery or to discharge
Title
Post-operative serum blood glucose concentration
Description
Serum blood glucose compiled on a daily basis
Time Frame
Within 30 days of surgery or to discharge
Title
Rate of peri-operative insulin use
Description
Whether insulin or an insulin infusion in the peri-operative period is used
Time Frame
Within 30 days of surgery or to discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Carbohydrate Loading and Diabetes in Colorectal Surgery
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