TerminatedPhase 4

Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

Stopped: The study was terminated following the Data and Safety Monitoring Board (DSMB) review due to concerns with perioperative use of the study drug.

United States28 participantsStarted 2019-03-08

Plain-language summary

This study is a prospective randomized study to examine the effects of exposure to dulaglutide on the prevention of stress-hyperglycemia and the metabolic inflammatory response in the perioperative period.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Hyperglycemia (BG\>125 mg/dl or HbA1c \> 6.5%) or previous treatment with antidiabetic agents * Impaired renal function (GFR \< 30 ml/min) or clinically significant hepatic failure * Gastrointestinal obstruction expected to require gastrointestinal suction * Patients with clinically relevant pancreatic or gallbladder disease * Treatment with oral or injectable corticosteroid * Mental condition rendering the subject unable to understand the possible consequences of the study * Pregnancy or breastfeeding at time of enrollment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period

Timeframe: During the hospital stay (up to 12 days postoperatively)

Trial details

NCT IDNCT03743025

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-02

Results submitted2024-05-02

View on ClinicalTrials.gov More Stress Hyperglycemia trials

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.