Carbohydrate Loading for Type 2 Diabetes in Colorectal Surgery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must be taking: Oral hypoglycemics

Must not be taking: Insulin

Disqualifiers: Under 18 years

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with type 2 diabetes who are scheduled for elective colorectal surgery at specified hospitals. It's only for those managing their diabetes with diet or oral medications, not insulin.

Inclusion Criteria

Only patients treated with diet or oral hypoglycemic agents will be included.

Exclusion Criteria

Subjects on insulin therapy preoperatively will be excluded.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants consume a carbohydrate drink or receive standard care prior to surgery

1 day

1 visit (in-person)

Surgery

Participants undergo elective colorectal surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for diabetes-related complications and other outcomes

30 days

Treatment Details

Interventions

• Pre-operative carbohydrate drink

Trial Overview The study is testing the safety of giving a carbohydrate drink (like juice) to patients with type 2 diabetes before they undergo colorectal surgery, to see if it can reduce complications and hospital stay time.

Participant Groups

Group I: Carbohydrate drink Experimental Treatment 1 Intervention

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

Group II: Standard Care Active Control 1 Intervention

Standard care for patients with diabetes pre-operatively .

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+