Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

What Was Tested

In this phase 4 trial, researchers set out to test Dulaglutide.

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

The registry classes the interventions as drug and other.

More on the Plan

Counterregulatory hormones and inflammatory mediators appear to modulate the acute biological response to stress, however, the pathophysiological pathways that result in stress hyperglycemia and its link to poor clinical outcomes are not well understood.

The current approach to treat hyperglycemia with insulin has major limitations including high resource utilization and high risk of hypoglycemia.

Who Took Part

The registry lists 28 actual participants took part.

It was open to people of any sex aged from 40 years up to 80 years.

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

Examples of who could join: Males or females between the ages of 40 and 80 years. Body mass index (BMI) ≥25. Undergoing elective CABG surgery. No previous history of diabetes or hyperglycemia.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: gastrointestinal obstruction expected to require gastrointestinal suction; patients with clinically relevant pancreatic or gallbladder disease; treatment with oral or injectable corticosteroid.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Dulaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Dulaglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Dulaglutide study: the participants and staff both knew the treatment.

It started in 2019-03-08 with completion listed for 2023-05-02.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Blood Glucose Levels (BG) > [amount hidden]/dl During Post Operative Period.

It also tracked 18 secondary outcomes, for example Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay Postoperatively, Number of Participants Needing CII Treatment in the ICU, Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII, Mean Blood Glucose Levels During the Hospital Stay, Mean Units Per Hour of Insulin While in the ICU and Duration of Continuous Insulin Infusion (CII).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Dulaglutide in 28 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.