Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

  • End date
    Oct 2, 2022
  • participants needed
  • sponsor
    Emory University
Updated on 2 August 2021


The 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


Stress hyperglycemia is common in the perioperative period and is associated with increased risk of death postoperatively. Counterregulatory hormones and inflammatory mediators appear to modulate the acute biological response to stress; however, the pathophysiological pathways that result in stress hyperglycemia and its link to poor clinical outcomes are not well understood. At least half of non-Diabetes Mellitus (DM) patients undergoing cardiac surgery develop stress hyperglycemia shown to be an independent risk factor of morbidity and mortality. The current approach to treat hyperglycemia with insulin has major limitations including high resource utilization and high risk of hypoglycemia.The main goals of the study are to examine baseline and postoperative metabolic profiles of non-diabetic CABG patients with stress hyperglycemia and to study the effect of a long-acting GLP-1 RA on the prevention of stress-hyperglycemia and modulation of metabolic stress during cardiac surgery.

The Study will be conducted in 2 Parts. The First part of the study aims to provide new insights into the mechanisms underlying the metabolic and inflammatory responses to surgical stress The first part is a nested case control study.The Second part of the study will examine whether exposure to a long acting glucagon like peptide-1 receptor agonist (GLP-1 RA), dulaglutide can improve glycemic control and ameliorate the inflammatory response to acute surgical stress. This study is a randomized study with assignment to either dulaglutide or placebo two to three days prior to surgery in non-Diabetes Mellitus obese patients (BG<126 mg/dL, HbA1c <6.5%, BMI >27, age> 45 years) undergoing CABG surgery.The study ultimately wants to provide evidence to support the use of novel therapies to prevent and manage stress hyperglycemia in the inpatient setting.

Condition Stress Hyperglycemia
Treatment Saline Injection, Dulaglutide Injection
Clinical Study IdentifierNCT03743025
SponsorEmory University
Last Modified on2 August 2021


Yes No Not Sure

Inclusion Criteria

Males or females between the ages of 45 and 80 years and BMI 27mg/kg2 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
subjects with 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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note