TerminatedPhase 4

Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

Stopped: This clinical trial was terminated on June 7, 2024 due to new information about contraindications of using the study drug in this population.

United States16 participantsStarted 2021-08-06

Plain-language summary

Hyperglycemia is seen in approximately 30% of patients who do not have a history of diabetes and undergo general surgery. Hyperglycemia in this setting is associated with increased risk of postoperative complications. The purpose of this study is to investigate risk factors for developing high sugars during the time of surgery, and if these high sugars can be prevented by the use of an injectable diabetes medication (dulaglutide) prior to surgery.

Who can participate

Age range

45 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: * 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)

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

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

Timeframe: During hospitalization (up to 5 days postoperatively)

Trial details

NCT IDNCT04862234

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-22

Results submitted2024-12-23

View on ClinicalTrials.gov More Hyperglycemia Stress trials