Overview

Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Emory University
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Treatments:
Anesthetics
Dulaglutide
Immunoglobulin Fc Fragments
Pharmaceutical Solutions
Criteria
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.