Pre-operative Carbohydrate Loading Patients With Diabetes Undergoing Elective Colorectal Surgery

NCT04495114 | Completed

• 1 other identifier: RES0034025
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Goal 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 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. 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 to aspiration due to delayed gastric emptying.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Preoperative glucose

  Mean difference in preoperative glucose between the two groups

  1 to 2 hours prior to operation time.

Study Arms (2)

Control Arm

NO INTERVENTION

Modern fasting guidelines without the carbohydrate load preoperatively.

Intervention Arm

EXPERIMENTAL

40g carbohydrate load preoperatively.

Other: 40g carbohydrate load (Apple juice)

Interventions

40g carbohydrate load (Apple juice) OTHER

A 40g carbohydrate drink will be administered to subjects with non-insulin dependent type 2 diabetes 3 hours prior to their operation. This is standard practice in subjects without diabetes.

Intervention Arm

Eligibility Criteria

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

You may qualify if:

• Type 2 diabetes, non-insulin dependent.
• Elective colorectal surgery patient at the University of Alberta Hospital, Grey Nuns Hospital, Misericordia Hospital, Foothills Hospital, or Royal Alexandra Hospital.

You may not qualify if:

• Insulin dependent type 2 diabetes

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, 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 Officials

• Haili Wang, MD

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 31, 2020
• Study Start: August 31, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CA (1)