Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

  • STATUS
    Recruiting
  • End date
    Oct 2, 2022
  • participants needed
    60
  • sponsor
    Emory University
Updated on 2 August 2021

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

Description

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.

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

Eligibility

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
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