ExeQOL

CompletedPhase 2, PHASE3

Impact of Perioperative Exenatide Infusion on Quality of Life in Cardiac Surgery Patients

Impact of Intravenous Exenatide Versus Insulin on Quality of Life in Cardiac Surgery Patients: an Ancillary Study of the ExSTRESS Phase II/III Clinical Trial

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Asset

Exenatide

Intravenous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Cardiovascular disease, Perioperative / gastric aspiration risk

Key I/E criterion

—

Primary endpoint

•SF-36 total

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 IDNCT02432976

Org study ID09/503

Timeline

Milestones

Study first posted2015-05-04estimated

Last update posted2021-03-09actual

Study start2015-05 (month precision)

Primary completion2017-01actual (month precision)

Study completion2017-01actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Cardiovascular diseasePerioperative / gastric aspiration risk

Eligibility

Who can enroll

Minimum age18 Years

Maximum age99 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age over 18.

•Patient consent.

•Non insulin requiring type 2 diabetic patients.

•Non diabetic patients.

•Planned coronary artery bypass graft (CABG) surgery.

•ASA (American Society of Anesthesiologists) score 1, 2, or 3.

Exclusion criteria

•Pregnancy and breast feeding.

•Pancreatectomy.

•Acute pancreatitis.

•Chronic pancreatitis.

•Type 1 diabetic patients.

•Insulin requiring type 2 patients.

•HbA1c>8%

•Ketoacidosis.

•Hyperosmolar coma.

•Preoperative blood glucose level above 300 mg/dl [21].

•Insulin or exenatide contraindication.

•History of renal transplantation or currently receiving renal dialysis or creatinine clearance below 60 ml/min.

•Emergency surgery.

•Planned non CABG cardiac surgery.

Endpoints (9)

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

Cardiovascular outcomes

Patient-reported / QoL

Other (unclassified)

Cardiovascular outcomes

4 endpoints

Secondary/protocol endpoint

1-month mortality

Time frame:1 month

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

3-months mortality

Time frame:3 months

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

6-months mortality

Time frame:6 month

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

12-months mortality

Time frame:12 months

All-cause death

time to event, event

SNOMED 419620001

Patient-reported / QoL

4 endpoints

Primary/protocol endpoint

Variation of the SF-36 score value at 3-months

Time frame:3 months

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Variation of the SF-36 score value at 1-month

Time frame:1 month

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Variation of the SF-36 score value at 6-months

Time frame:6 months

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Variation of the SF-36 score value at 12-months

Time frame:12 months

SF-36 total

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Postoperative left ventricular function

Time frame:Day 7

descriptive

Publications (5)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Efficacy and safety of an insulin infusion protocol during and after cardiac surgery.
Diabetes & metabolism2010 Feb (month)PMID20097589doi:10.1016/j.diabet.2009.05.008via CT.gov background
Effect of glucagon-like peptide-1 (GLP-1) on glycemic control and left ventricular function in patients undergoing coronary artery bypass grafting.
The American journal of cardiology2007 Sep 1PMID17719327doi:10.1016/j.amjcard.2007.05.022via CT.gov background
Glucagon-like peptide-1 infusion improves left ventricular ejection fraction and functional status in patients with chronic heart failure.
Journal of cardiac failure2006 Dec (month)PMID17174230doi:10.1016/j.cardfail.2006.08.211via CT.gov background
Improving glycemic control in the cardiothoracic intensive care unit: clinical experience in two hospital settings.
Journal of cardiothoracic and vascular anesthesia2004 Dec (month)PMID15650975doi:10.1053/j.jvca.2004.08.003via CT.gov background
Validation of a French-language version of the MOS 36-Item Short Form Health Survey (SF-36) in young healthy adults.
Journal of clinical epidemiology1995 Aug (month)PMID7775992doi:10.1016/0895-4356(94)00227-hvia CT.gov background

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.