GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT04862234

TerminatedPhase 4Results posted

Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

Lead sponsor

Emory University

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Perioperative / gastric aspiration risk, Prediabetes / glucose intolerance

Key I/E criterion

•BMI ≥30

Primary endpoint

•CGM time-in-range

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 IDNCT04862234

Org study IDIRB00097659

Secondary IDK23DK122199

Timeline

Milestones

Study first posted2021-04-27actual

Study start2021-08-06actual

Primary completion2023-06-22actual

Study completion2023-06-22actual

Last update posted2025-01-17actual

Results first posted2025-01-17actual

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Obesity / overweightPerioperative / gastric aspiration riskPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age45 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Men and women without known history of diabetes with ages between 45 and 80 years undergoing non-cardiac general or vascular surgery

•BMI ≥30 kg/m2 and pre-DM or DM by OGTT or HbA1c

Exclusion criteria

•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

•Severely impaired renal function (eGFR < 30 mL/min) or clinically significant hepatic failure

•Treatment with oral (equivalent to prednisone > 5 mg/day) or injectable corticosteroids

•Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study; unable to consent

•Pregnant or breast feeding at time of enrollment

•Prisoners

•Patients undergoing gastrointestinal surgery or at high risk for gastrointestinal obstruction/ileus or expected to require gastrointestinal suction

•Patients with delayed gastric emptying, pancreatic or gallbladder disease

•Patients with personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)

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

Glycemic / diabetes

Cardiometabolic biomarkers

Other (unclassified)

Safety / tolerability / PK

Glycemic / diabetes

17 endpoints

Primary/registry result

Percentage of Time in Target Glucose Range (70-140 mg/dL) by CGM

Time frame:During hospitalization (up to 5 days postoperatively)

CGM time-in-range

descriptive, improvement

Posted result

Group	Value (mean), percentage of time	95% CI
Dulaglutide	84.19	—
Placebo	71.82	—

Primary/protocol endpoint

Percentage of Time in Target Glucose Range (70-140 mg/dL) by CGM

Time frame:During hospitalization (up to 5 days postoperatively)

CGM time-in-range

threshold achievement, improvement

Secondary/registry result

Percentage of Time in Hyperglycemia (Glucose>140 mg/dL)

Time frame:During hospitalization (up to 5 days postoperatively)

CGM time-above-range

descriptive, improvement

Secondary/registry result

Percentage of Time in Hyperglycemia (Glucose>180 mg/dL)

Time frame:During hospitalization (up to 5 days postoperatively)

CGM time-above-range

descriptive, improvement

Secondary/registry result

Percentage of Time in Hypoglycemia (Glucose <70 mg/dL)

Time frame:During hospitalization (up to 5 days postoperatively)

CGM time-below-range

descriptive, improvement

Secondary/registry result/low confidence

Mean Onset of Stress Hyperglycemia During the Postoperative Period

Time frame:During hospitalization (up to 5 days postoperatively)

descriptive

Secondary/registry result/low confidence

Mean Duration of Stress Hyperglycemia During the Postoperative Period

Time frame:During hospitalization (up to 5 days postoperatively)

descriptive

Secondary/registry result

Mean Daily Glucose Values

Time frame:During hospitalization (up to 5 days postoperatively)

descriptive

Secondary/registry result/low confidence

Maximum Daily Glucose Values

Time frame:During hospitalization (up to 5 days postoperatively)

descriptive

Secondary/registry result/low confidence

Perioperative Insulin Requirements

Time frame:During hospitalization (up to 5 days postoperatively)

descriptive

Secondary/protocol endpoint

Percentage of Time in Hyperglycemia (Glucose>140 mg/dL)

Time frame:During hospitalization (up to 5 days postoperatively)

CGM time-above-range

descriptive, improvement

Secondary/protocol endpoint

Percentage of Time in Hyperglycemia (Glucose>180 mg/dL)

Time frame:During hospitalization (up to 5 days postoperatively)

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean Onset of Stress Hyperglycemia During the Postoperative Period

Time frame:During hospitalization (up to 5 days postoperatively)

descriptive

Secondary/protocol endpoint

Mean Duration of Stress Hyperglycemia During the Postoperative Period

Time frame:During hospitalization (up to 5 days postoperatively)

descriptive, improvement

Secondary/protocol endpoint

Mean Daily Glucose Values

Time frame:During hospitalization (up to 5 days postoperatively)

descriptive

Secondary/protocol endpoint

Maximum Daily Glucose Values

Time frame:During hospitalization (up to 5 days postoperatively)

descriptive

Secondary/protocol endpoint

Perioperative Insulin Requirements

Time frame:During hospitalization (up to 5 days postoperatively)

descriptive

Cardiometabolic biomarkers

6 endpoints

Secondary/registry result

Change in Level of Free Fatty Acids (FFA)

Time frame:Baseline, 48 to 72 hours postoperatively

Free fatty acids, change

change from baseline, improvement

Secondary/registry result

Change in High Sensitivity C-reactive Protein (hsCRP) Level

Time frame:Baseline, 48 to 72 hours postoperatively

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/registry result

Change in Adiponectin Level

Time frame:Baseline, 48 to 72 hours postoperatively

Adiponectin, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Level of Free Fatty Acids (FFA)

Time frame:Baseline, 48 to 72 hours postoperatively

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change in High Sensitivity C-reactive Protein (hsCRP) Level

Time frame:Baseline, 48 to 72 hours postoperatively

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Adiponectin Level

Time frame:Baseline, 48 to 72 hours postoperatively

Adiponectin, change

change from baseline, improvement

Safety / tolerability / PK

5 endpoints

Secondary/registry result

Percentage of Time in Hypoglycemia (Glucose <54 mg/dL)

Time frame:During hospitalization (up to 5 days postoperatively)

Documented hypoglycemia

percent change from baseline, event

Secondary/registry result

Percentage of Time in Hypoglycemia (Glucose <40 mg/dL)

Time frame:During hospitalization (up to 5 days postoperatively)

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint/low confidence

Percentage of Time in Hypoglycemia (Glucose <70 mg/dL)

Time frame:During hospitalization (up to 5 days postoperatively)

percent change from baseline, event

Secondary/protocol endpoint

Percentage of Time in Hypoglycemia (Glucose <54 mg/dL)

Time frame:During hospitalization (up to 5 days postoperatively)

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Percentage of Time in Hypoglycemia (Glucose <40 mg/dL)

Time frame:During hospitalization (up to 5 days postoperatively)

Documented hypoglycemia

threshold achievement, event

Other (unclassified)

6 endpoints

Secondary/registry result/low confidence

Change in Plasma Cortisol Level

Time frame:Baseline, 48 to 72 hours postoperatively

change from baseline, descriptive

Secondary/registry result/low confidence

Change in Tumor Necrosis Factor-alpha (TNF-α) Level

Time frame:Baseline, 48 to 72 hours postoperatively

change from baseline, descriptive

Secondary/registry result/low confidence

Change in Level of Thiobarbituric Acid Reactive Substances (TBARS)

Time frame:Baseline, 48 to 72 hours postoperatively

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Plasma Cortisol Level

Time frame:Baseline, 48 to 72 hours postoperatively

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Tumor Necrosis Factor-alpha (TNF-α) Level

Time frame:Baseline, 48 to 72 hours postoperatively

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Level of Thiobarbituric Acid Reactive Substances (TBARS)

Time frame:Baseline, 48 to 72 hours postoperatively

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.