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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
40g carbohydrate load (Apple juice)
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Insulin dependent type 2 diabetes

Sites / Locations

  • University of Alberta Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Arm

Intervention Arm

Arm Description

Modern fasting guidelines without the carbohydrate load preoperatively.

40g carbohydrate load preoperatively.

Outcomes

Primary Outcome Measures

Preoperative glucose
Mean difference in preoperative glucose between the two groups

Secondary Outcome Measures

Full Information

First Posted
July 23, 2020
Last Updated
July 30, 2020
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT04495114
Brief Title
Pre-operative Carbohydrate Loading Patients With Diabetes Undergoing Elective Colorectal Surgery
Official Title
Pre-operative Carbohydrate Loading Patients With Diabetes Undergoing Elective Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Fasting prior to the administration of a general anesthetic has been the standard of peri-operative care for many years. The refrain of "nothing to eat or drink after midnight" has become synonymous with surgery for both clinicians and the general public. The rationale behind this practice has been to reduce the risk of regurgitation of gastric contents. In addition, this instruction is straightforward for patients and ancillary staff, and allows for easy alteration of the order of cases on the operative list. Despite the widespread nature of this practice, a 2003 Cochrane review attempted to define the optimum duration of fasting, type of fasting, and volume of intake permitted and concluded that there was no evidence to suggest a shortened fluid fast resulted in an increased risk of aspiration, regurgitation, or morbidity in healthy patients. Pre-operative fasting leads to insulin resistance and metabolic stresses. More recently it has been suggested that a preoperative carbohydrate loading may alleviate some deleterious effects of this fast. This strategy, combined with a number of others, have been recently introduced in many Enhanced Recovery After Surgery (ERAS) programs, that have led to improved postoperative pain, faster restoration of GI function, decreased LOS and decreased complication rate after colon surgery. Type 2 diabetes is a disease of impaired glucose tolerance. It is a common condition that affects over 15% of general surgical patients undergoing major abdominal surgery. It is well recognized that this is a high-risk surgical population that is at increased risk of perioperative complications such as anastomotic dehiscence, poor wound healing, and postoperative ileus which can lead to an increased LOS after surgery. However, there is a relative dearth of robust evidence regarding preoperative fasting in patients with type 2 diabetes so there is no consensus among professional association guidelines internationally on recommendations for carbohydrate loading in this population undergoing elective surgery. Two major concerns have been raised; first the risk of aspiration in diabetic patients with a significant neuropathy and gastroparesis, and second potential for hyperglycemia and its deleterious effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Modern fasting guidelines without the carbohydrate load preoperatively.
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
40g carbohydrate load preoperatively.
Intervention Type
Other
Intervention Name(s)
40g carbohydrate load (Apple juice)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preoperative glucose
Description
Mean difference in preoperative glucose between the two groups
Time Frame
1 to 2 hours prior to operation time.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Insulin dependent type 2 diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haili Wang, MD
Organizational Affiliation
Alberta Health services
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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