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NCT03743025·Phase 4·INTERVENTIONAL

Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

DulaglutideWeight lossTerminated

Status

Terminated

Phase

Phase 4

Enrollment

28

Locations

3

Results

Posted

Publications

0

Study summary

What the protocol is testing.

This 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.

Full 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 this study are to examine baseline and postoperative metabolic profiles of non-diabetic, coronary artery bypass grafting (CABG) patients with stress hyperglycemia and to study the effect of a long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RA) on the prevention of stress-hyperglycemia and modulation of metabolic stress during cardiac surgery. To examine whether exposure to dulaglutide, a GLP-1 RA, can improve glycemic control and ameliorate the inflammatory response to acute surgical stress, obese patients without diabetes mellitus undergoing CABG surgery will be randomized to receive either dulaglutide or placebo two to three days prior to surgery. The researchers of this study ultimately want to provide evidence to support the use of novel therapies to prevent and manage stress hyperglycemia in the inpatient setting.

Interventions

Treatment arms and agents.

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

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

Timeline

From registration to results.

  1. First posted

    Nov 15, 2018

  2. Study start

    Mar 8, 2019

  3. Primary completion

    May 2, 2023

  4. Study completion

    May 2, 2023

  5. Results posted

    May 30, 2024

  6. Registry updated

    May 30, 2024

Outcomes

What the study measures.

Primary outcomes

Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period

Time frame · During the hospital stay (up to 12 days postoperatively)

Stress-hyperglycemia is defined as any post-CABG hospital-obtained blood glucose (BG) levels \>140 milligrams per deciliter (mg/dL). Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.

Secondary outcomes

Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay Postoperatively

Time frame · During the ICU stay (up to 7 days postoperatively)

To measure glucose control, the mean blood glucose levels in mg/dL were measured during the postoperative Intensive Care Unit (ICU) stay. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.

Number of Participants Needing CII Treatment in the ICU

Time frame · During the ICU stay (up to 7 days postoperatively)

Patients with two consecutive BG \>180 mg/dl, or average daily BG \>180 mg/dl were started on rescue therapy with subcutaneous basal insulin (glargine or levemir) once daily. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. The number of participants needing CII while in the ICU postoperatively was compared between patients randomized to dulaglutide or placebo study arms.

Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII

Time frame · During the hospital stay (up to 12 days postoperatively)

Patients with two consecutive BG \>180 mg/dl, or an average daily BG \>180 mg/dl were started on rescue therapy with subcutaneous basal insulin (glargine or levemir) once daily. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. The number of participants in need of rescue therapy with subcutaneous insulin postoperatively, after CII was discontinued, was compared between study arms.

Mean Blood Glucose Levels During the Hospital Stay

Time frame · During the hospital stay (up to 12 days postoperatively)

To measure glucose control, the mean blood glucose levels in mg/dL during the non-ICU hospital stay postoperatively were measured. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.

Mean Units Per Hour of Insulin While in the ICU

Time frame · During the ICU stay (up to 7 days postoperatively)

The mean insulin dose during the time that participants were in the ICU is assessed as insulin infusion units per hour.

Mean Insulin Dose Per Day While in the ICU

Time frame · During the ICU stay (up to 7 days postoperatively)

The mean insulin dose during the time that participants were in the ICU is assessed as insulin units per day.

Duration of Continuous Insulin Infusion (CII)

Time frame · During the hospital stay (up to 12 days postoperatively)

The duration of continuous insulin infusion (CII) is assessed in hours.

Days of Subcutaneous (SC) Insulin After Discontinuation of CII

Time frame · During the hospital stay (up to 12 days postoperatively)

Subcutaneous (SC) insulin use after continuous insulin infusion (CII) is discontinued is assessed as the number of days that SC insulin was required.

Amount of SC Insulin Administered

Time frame · During the hospital stay (up to 12 days postoperatively)

The amount of subcutaneous (SC) insulin administered during the ICU and non-ICU hospital stay, among participants requiring SC insulin after discontinuing CII.

Number of Participants Experiencing Hyperglycemic Events

Time frame · During the hospital stay (up to 12 days postoperatively)

Hyperglycemic events are defined as BG \> 200 mg/dl, during ICU and non-ICU hospital stay.

Eligibility

Who can take part.

Minimum age
40 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Males or females between the ages of 40 and 80 years * Body mass index (BMI) ≥25 * 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 * 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

Study locations

3 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Grady Memorial Hospital

Atlanta, Georgia, United States

Emory Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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