Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

What Was Tested

This registered phase 4 trial tested Dulaglutide.

It had two arms (groups): Dulaglutide (experimental) and Placebo (placebo comparator).

Participants randomized to receive dulaglutide within 72 hours prior to a planned surgery.

Participants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery.

The registry classes the interventions as device and drug.

More on the Plan

However, no prospective studies have comprehensively examined preoperative glycemic control profiles and their association with the incidence, clinical predictors and underlying mechanisms of SH in general surgical patients.

Accordingly, the researchers propose a prospective study investigating clinical, metabolic and inflammatory/oxidative stress biomarker profiles leading to SH.

This study will use continuous glucose monitoring (CGM) technology to fully characterize the onset, duration and severity of SH during the perioperative period.

In addition, the researchers will explore the role of beta-cell function, insulin resistance, and inflammation on the pathogenesis of stress hyperglycemia.

Who Took Part

16 actual participants took part.

It was open to people of any sex aged from 45 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: BMI ≥30 kg/m2 and pre-DM or DM by OGTT or HbA1c.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: patients prescribed or taking antihyperglycemic medications; patients undergoing cardiac surgery or patients anticipated to require icu care; patients expected to be admitted less than 48-72 hours after surgery.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Dulaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2021-08-06 with completion listed for 2023-06-22.

It ran at 2 sites in United States (2).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Percentage of Time in Target Glucose Range ([amount hidden]/dL) by CGM.

It also tracked 16 secondary outcomes, for example Mean Onset of Stress Hyperglycemia During the Postoperative Period, Mean Duration of Stress Hyperglycemia During the Postoperative Period, Mean Daily Glucose Values, Maximum Daily Glucose Values, Perioperative Insulin Requirements and Change in Plasma Cortisol Level.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Dulaglutide in 16 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Dulaglutide compound page, all human trials.