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Carbohydrate Loading and Diabetes in Colorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04410419
Recruitment Status : Active, not recruiting
First Posted : June 1, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Laffin, University of Alberta

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Surgery Surgery--Complications Dietary Supplement: Pre-operative carbohydrate drink Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: In Individuals With Diabetes Undergoing Elective Colorectal Surgery, Is Carbohydrate Loading Preoperatively Safe? A Pilot Randomized Controlled Trial
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410419


Locations
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Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
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Responsible Party: Michael Laffin, Investigator, University of Alberta
ClinicalTrials.gov Identifier: NCT04410419    
Other Study ID Numbers: Carbs Drink in Colorectal
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases