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Completed

NCT Number: NCT04410419

Carbohydrate Loading and Diabetes in Colorectal Surgery

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Surgery Surgery--Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pre-operative carbohydrate drink

Dietary Supplement

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

Primary outcomes

  1. Mean difference of preoperative glucose between the two groups

    Time frame: Pre-operative

    Examined in a non-inferiority fashion with NI margin set as 2mmol/L

Secondary outcomes

  1. Composite outcome of diabetes-related complications

    Time frame: Within 30 days of surgery or to discharge

    hypoglycemia, DKA, cancellation of surgery, ketosis or perioperative aspiration

  2. length of stay

    Time frame: Within 30 days of surgery or to discharge

    How long the patient stays in hospital after surgery in days

  3. Surgical site infection

    Time frame: Within 30 days of surgery or to discharge

    Whether a wound infection is noted in hospital

  4. Postoperative complications using the Clavien Dindo scale

    Time frame: Within 30 days of surgery or to discharge

    A composite measure of post-operative complications stratified based on the Clavien Dindo scale from 1-5 with increasing severity from 1 to 5.

  5. Post-operative serum blood glucose concentration

    Time frame: Within 30 days of surgery or to discharge

    Serum blood glucose compiled on a daily basis

  6. Rate of peri-operative insulin use

    Time frame: Within 30 days of surgery or to discharge

    Whether insulin or an insulin infusion in the peri-operative period is used

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2020
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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