GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 3

Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery

Perioperative Application of Liraglutide for the Prevention of Postoperative Delirium Among Elderly Patients with Type 2 Diabetes Undergoing Cardiac Surgery: a Single-Center Randomized Controlled Study

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

260

estimated

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Delirium

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06361238

Org study ID2023-LCYJ-PY-21

Timeline

Milestones

Study first posted2024-04-11actual

Study start2024-11-19actual

Last update posted2024-12-20actual

Primary completion2027-03-31estimated

Study completion2028-03-31estimated

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Age ≥ 60 years

2. Type 2 diabetes

3. Patients undergoing elective cardiac surgery

Exclusion criteria

1. History of neurological or psychiatric disorders, such as schizophrenia, epilepsy, Parkinson's disease, severe dementia, etc

2. Patients with communication difficulties, such as severe visual, auditory, or speech impairments

3. History of central nervous system damage or surgery

4. Cardiac function NYHA Class IV

5. Severe liver dysfunction (Child-Pugh Class C)

6. Severe renal failure requiring renal replacement therapy

7. History of pancreatitis

8. Type 1 diabetes

9. Patients whose blood sugar is difficult to control within 4-8 mmol/L during the screening period

10. Patients with medullary thyroid carcinoma or a family history of it

11. Pregnant or breastfeeding women

12. Intolerance or allergy to liraglutide

13. Previous use of GLP-1A and SGLT2i

14. Patients who refuse to sign the informed consent

Endpoints (34)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Other clinical outcomes

Cardiovascular outcomes

Heart failure

Cardiometabolic biomarkers

Patient-reported / QoL

MASH / liver

Safety / tolerability / PK

Cardiovascular outcomes

2 endpoints

Secondary/protocol endpoint

In-hospital mortality

Time frame:The time from hospital admission to discharge, assessed up to 12months.

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Rate of major cardiovascular adverse events

Time frame:Within 1 year post-surgery (including cardiovascular death, myocardial infarction, and stroke)

3-point MACE

composite event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

MASH / liver

1 endpoint

Secondary/protocol endpoint

Serum levels of AST

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

AST, change

change from baseline, improvement

LOINC 1920-8

Heart failure

2 endpoints

Secondary/protocol endpoint

Serum levels of BNP

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

NT-proBNP, change

change from baseline, improvement

Secondary/protocol endpoint

Ejection Fraction (EF)

Time frame:One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

descriptive

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Serum levels of CRP

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint/low confidence

Serum levels of cTNT

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

concentration, descriptive

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Anxiety

Time frame:One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

change from baseline, improvement

Secondary/protocol endpoint

Depression

Time frame:One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Incidence of adverse events

Time frame:One day preoperatively to three days Postoperatively.

Treatment-emergent AEs (any)

event count, event

Other clinical outcomes

6 endpoints

Primary/protocol endpoint

The incidence of delirium

Time frame:One day before surgery and within the first seven days after surgery.

categorical status, event

Secondary/protocol endpoint

The severity of delirium

Time frame:One day before surgery and within the first seven days after surgery.

descriptive, improvement

Secondary/protocol endpoint

Cognitive function

Time frame:One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

descriptive, improvement

Secondary/protocol endpoint

Duration of ICU stay

Time frame:The time from transfer into the ICU to discharge from the ICU, assessed up to 12months.

descriptive

Secondary/protocol endpoint

Mechanical ventilation time

Time frame:The time from tracheal intubation to the removal of the tracheal tube, assessed up to 12months.

time to event, improvement

Secondary/protocol endpoint

Duration of hospital stay

Time frame:The time from hospital admission to discharge, assessed up to 12months.

descriptive

Other (unclassified)

18 endpoints

Secondary/protocol endpoint/low confidence

Serum levels of NSE

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

concentration, descriptive

Secondary/protocol endpoint/low confidence

Serum levels of IL-1α

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

concentration, descriptive

Secondary/protocol endpoint/low confidence

Serum levels of TNF-α

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

concentration, descriptive

Secondary/protocol endpoint/low confidence

Serum levels of C3

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

descriptive

Secondary/protocol endpoint/low confidence

Serum levels of LDH

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

concentration, descriptive

Secondary/protocol endpoint/low confidence

Serum levels of CK

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

descriptive

Secondary/protocol endpoint/low confidence

Serum levels of CK-MB

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

descriptive

Secondary/protocol endpoint/low confidence

Serum levels of C1q

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

concentration, descriptive

Secondary/protocol endpoint/low confidence

Serum levels of IL-1β

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

concentration, descriptive

Secondary/protocol endpoint/low confidence

Serum levels of IL-6

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

concentration, descriptive

Secondary/protocol endpoint/low confidence

Serum levels of S100β

Time frame:One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively

concentration, descriptive

Secondary/protocol endpoint/low confidence

Left Ventricular Posterior Wall Thickness in Diastole (LVPWTd)

Time frame:One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

descriptive

Secondary/protocol endpoint/low confidence

Left Ventricular End-Diastolic Dimension (LVDd)

Time frame:One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

descriptive

Secondary/protocol endpoint/low confidence

Left Ventricular End-Systolic Diameter (LVDs)

Time frame:One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

descriptive

Secondary/protocol endpoint/low confidence

Left Atrial Diameter (LAD)

Time frame:One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

descriptive

Secondary/protocol endpoint/low confidence

Fractional Shortening (FS)

Time frame:One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

descriptive

Secondary/protocol endpoint/low confidence

Early Diastolic Velocity/Atrial Diastolic Velocity (E/A)

Time frame:One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

ratio, descriptive

Secondary/protocol endpoint/low confidence

Interventricular Septum Thickness in Diastolic (IVSTd)

Time frame:One day preoperatively; One week postoperatively or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.