What side effects are associated with this type of intervention?

Common treatments for high blood sugar include insulin therapy and various oral hypoglycemic agents. Insulin therapy can lead to hypoglycemia, weight gain, and injection site reactions. Metformin, a widely used oral agent, often causes gastrointestinal issues such as nausea and diarrhea. Sulfonylureas can result in hypoglycemia and weight gain, while thiazolidinediones are linked to weight gain, edema, and an increased risk of fractures. Sodium-glucose cotransporter 2 (SGLT2) inhibitors may cause urinary tract infections and, rarely, Fournier's gangrene.

What prior FDA approvals exist?

The FDA has approved several treatments for high blood sugar, particularly relevant to the multi-disciplinary approach seen in the Perioperative Glycemic Management Pathway (PGMP). Insulin therapies, such as insulin glargine and premixed insulins, are commonly used for tight glycemic control. GLP-1 receptor agonists like liraglutide and semaglutide have also been approved and are noted for their efficacy in reducing blood glucose levels and promoting weight loss. Additionally, DPP-4 inhibitors such as sitagliptin have been approved for their cardiovascular safety and effectiveness in lowering blood sugar. These treatments, often used in combination, form the cornerstone of managing perioperative hyperglycemia in diabetic patients.

What other types of research exist?

Promising alternatives to the Perioperative Glycemic Management Pathway (PGMP) for managing high blood sugar in surgical patients include: 1) GLP-1 receptor agonists such as semaglutide, which have shown efficacy in weight loss and glycemic control; 2) Metabolic surgery, including procedures like gastric bypass, which have demonstrated significant improvements in glycemic control and diabetes remission; 3) Dual GIP and GLP-1 receptor agonists like tirzepatide, which have shown promising results in clinical trials for glycemic control and weight management. These alternatives should be considered in consultation with healthcare providers to tailor the best approach for individual patient needs.

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Glycemic Management for High Blood Sugar in Surgical Patients

N/A

Waitlist Available

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing a surgical procedure, adults (older than 18 years of age), admitted to the hospital for more than 24 hours after their surgical procedure.

Be older than 18 years old

Must not have

Under 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks after the index surgical procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special care plan called PGMP to manage blood sugar in surgical patients at risk of high levels. It aims to improve recovery by monitoring and controlling blood sugar, reducing complications, and shortening hospital stays.

Who is the study for?

This trial is for adults over 18 who are undergoing surgery and will be in the hospital for more than a day afterward. It's designed to help those at risk of high blood sugar after their operation, including people with known or undiagnosed diabetes.

What is being tested?

The trial tests a Perioperative Glycemic Management Pathway (PGMP) against usual care to see if it can better manage post-surgery blood sugar levels, shorten hospital stays, reduce readmissions, and save costs. The study involves multiple hospitals and uses a stepped-wedge design.

What are the potential side effects?

Since this intervention focuses on managing blood sugar levels around the time of surgery rather than medication side effects per se, specific side effects aren't listed but may include risks associated with any changes in glycemic control.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult who will be in the hospital for more than a day after surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~365 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Length of stay

Secondary study objectives

Hypoglycemia

Readmissions

Other study objectives

Surgical site infections

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Intervention: PGMPActive Control1 Intervention

Sites will implement a perioperative glycemic management pathway based on national guidelines and current evidence, with support of an implementation scientist team.

Group II: Non-intervention: usual careActive Control1 Intervention

Sites will perform usual perioperative glycemic management.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood sugar include insulin therapy and GLP-1 receptor agonists. Insulin therapy lowers blood glucose by promoting cellular glucose uptake and reducing hepatic glucose production. GLP-1 receptor agonists enhance meal-induced insulin secretion, inhibit glucagon release, and slow gastric emptying. These mechanisms are vital for high blood sugar patients, particularly in perioperative settings, to prevent complications like infections, extended hospital stays, and increased mortality.

Protocol for a prospective, international cohort study on the Management and Outcomes of Perioperative Care among European Diabetic Patients (MOPED).Diabetes and cardiovascular disease: from new mechanisms to new therapies.Perioperative Glycemic Management of Patients Undergoing Bariatric Surgery.