Carbohydrate Loading and Diabetes in Colorectal Surgery

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04410419
• Other study ID #: Carbs Drink in Colorectal
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Surgery
• Surgery--Complications

Intervention

Dietary Supplement:
• Pre-operative carbohydrate drink
Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Composite outcome of diabetes-related complications	hypoglycemia, DKA, cancellation of surgery, ketosis or perioperative aspiration	Within 30 days of surgery or to discharge
Secondary	length of stay	How long the patient stays in hospital after surgery in days	Within 30 days of surgery or to discharge
Secondary	Surgical site infection	Whether a wound infection is noted in hospital	Within 30 days of surgery or to discharge
Secondary	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
Secondary	Post-operative serum blood glucose concentration	Serum blood glucose compiled on a daily basis	Within 30 days of surgery or to discharge
Secondary	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