Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery

What Was Tested

The trial (phase 3) is built around Liraglutide.

It had two arms (groups): Liraglutide Group (experimental) and Vehicle Group (placebo comparator).

Subcutaneous injection of liraglutide.

Subcutaneous injection of vehicle.

The registry classes the interventions as drug.

More on the Plan

Delirium is the most prevalent neurological complication following cardiac surgery.

It is characterized by an acute and fluctuating disturbance in consciousness, attention, and cognitive function.

Currently, it is widely recognized that the development of delirium is influenced by multiple factors, including advanced age, diabetes, surgical and anesthetic techniques, depression, baseline cognitive function, and infections, among others.

Inflammatory responses, crucial for protecting against external or internal threats, can, following surgery, lead to neuroinflammation and neurological damage due to elevated postoperative inflammatory markers and blood-brain barrier disruption.

Who Took Part

260 planned participants were the target.

It was open to people of any sex aged from 60 years with no upper age limit.

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

Examples of who could join: Age ≥ 60 years. Type 2 diabetes. Patients undergoing elective cardiac surgery.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: history of neurological or psychiatric disorders, such as schizophrenia, epilepsy, parkinson's disease, severe dementia, etc; patients with communication difficulties, such as severe visual, auditory, or speech impairments; history of central nervous system damage or surgery.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2024-11-19 with completion listed for 2027-03-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The incidence of delirium (time frame: One day before surgery and within the first seven days after surgery).

It also tracked 33 secondary outcomes, for example The severity of delirium, Cognitive function, Anxiety, Depression, Duration of ICU stay and Mechanical ventilation time.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 260 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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