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Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743025
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Francisco Pasquel, MD, MPH, Emory University

Brief 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

Condition or disease Intervention/treatment Phase
Stress Hyperglycemia Drug: Dulaglutide Injection Other: Saline Injection Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Placebo controlled randomized study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arm Intervention/treatment
Experimental: Dulaglutide Arm
Participants randomized at pre-surgery/anesthesia visit and without a history of DM will receive a single injection of Dulaglutide injection: 0.75 mg/0.5 mL solution in a single-dose pen 1 to 3 days prior to surgery
Drug: Dulaglutide Injection
Participants randomized at pre-surgery/anesthesia visit and without a history of DM will receive a single injection of Dulaglutide injection: 0.75 mg/0.5 mL solution in a single-dose pen 1 to 3 days prior to surgery
Other Name: Trulicity

Placebo Comparator: Placebo Arm
Participants randomized at pre-surgery/anesthesia visit and without a history of DM will receive a single injection of Saline injection/0.5 mL pre-drawn solution 1 to 3 days prior to surgery
Other: Saline Injection
Participants randomized at pre-surgery/anesthesia visit and without a history of DM will receive a single injection of Saline injection/0.5 mL pre-drawn solution 1 to 3 days prior to surgery
Other Name: Sodium Chloride Injection




Primary Outcome Measures :
  1. Frequency of Blood Glucose levels (BG) > 140 mg/dl during post operative period between patients randomized to dulaglutide or placebo arms [ Time Frame: Up to 7 days postoperatively ]
    Stress-hyperglycemia is defined as Blood Glucose levels >140 mg/dl and requiring insulin therapy during the postoperative period. To to determine if dulaglutide can prevent stress-hyperglycemia, number of Blood Glucose levels (BG) > 140 mg/dl during post operative period between patients randomized to dulaglutide or placebo arms are recorded and compared. Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected. BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.


Secondary Outcome Measures :
  1. Mean blood glucose levels in mg/dL during the Intensive Care Unit (ICU) stay post operatively between patients randomized to dulaglutide or placebo arms [ Time Frame: During the ICU stay (Up to 5 days postoperatively) ]
    To measure glucose control the mean blood glucose levels in mg/dL during the Intensive Care Unit (ICU) stay post operatively are measured between patients randomized to dulaglutide or placebo arms. Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected. BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.

  2. Mean blood glucose levels in mg/dL during the hospital stay post operatively between patients randomized to dulaglutide or placebo arms [ Time Frame: During the hospital stay (Up to 7 days postoperatively) ]
    To measure glucose control the mean blood glucose levels in mg/dL during the hospital stay post operatively are measured between patients randomized to dulaglutide or placebo arms. Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected. BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.

  3. Frequency of rescue therapy with subcutaneous insulin after transition to regular floor post operatively between patients randomized to dulaglutide or placebo arms [ Time Frame: During the hospital stay (Up to 7 days postoperatively) ]
    Patients with 2 consecutive BG >180 mg/dl, or average daily BG >180 mg/dl will be started on rescue therapy with subcutaneous basal insulin (glargine or levemir) once daily. Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected. BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.The Frequency of rescue therapy with subcutaneous insulin after transition to regular floor post operatively between patients randomized to dulaglutide or placebo arms is recorded and compared



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743025


Contacts
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Contact: Francisco Pasquel, MD, MPH 404- 778 1695 fpasque@emory.edu
Contact: Saumeth Cardona, MD, MPH 404-251-8957 scardon@emory.edu

Locations
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United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Francisco Pasquel, M.D, M.P.H    404-778-1695    fpasque@emory.edu   
Principal Investigator: Francisco Pasquel, M.D, M.P.H         
Emory Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Francisco Pasquel, MD, MPH    404-778-1695    fpasque@emory.edu   
Principal Investigator: Francisco Pasquel, MD, MPH         
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Guillermo Umpierrez, MD    404-778-1665    GEUMPIE@emory.edu   
Contact: MD         
Sponsors and Collaborators
Emory University
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: Francisco Pasquel, MD, MPH Emory University
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Responsible Party: Francisco Pasquel, MD, MPH, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03743025    
Other Study ID Numbers: IRB00097963
1K23GM128221-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Francisco Pasquel, MD, MPH, Emory University:
Coronary Artery Bypass Surgery (CABG)
Post Operative
Obesity
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Dulaglutide
Hypoglycemic Agents
Physiological Effects of Drugs