Carbohydrate Loading and Diabetes in Colorectal Surgery

NCT04410419 | Completed

• 1 other identifier: Carbs Drink in Colorectal
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Composite outcome of diabetes-related complications

  Within 30 days of surgery or to discharge

• length of stay

  Within 30 days of surgery or to discharge

• Surgical site infection

  Within 30 days of surgery or to discharge

• Postoperative complications using the Clavien Dindo scale

  Within 30 days of surgery or to discharge

• Post-operative serum blood glucose concentration

  Within 30 days of surgery or to discharge

Study Arms (2)

Standard Care

NO INTERVENTION

Standard care for patients with diabetes pre-operatively .

Carbohydrate drink

EXPERIMENTAL

Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery

Dietary Supplement: Pre-operative carbohydrate drink

Interventions

Pre-operative carbohydrate drink DIETARY_SUPPLEMENT

Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery

Carbohydrate drink

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 1, 2020
• Study Start: March 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)