Stress HyperglycemiaPhase 4NCT03743025
Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients
A Phase 4 study testing Dulaglutide Injection and Saline Injection in people with Stress Hyperglycemia, run by Emory University at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stress Hyperglycemia
- What is being tested?
- Dulaglutide Injection and Saline Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Mar 2019to 2 May 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
About this study
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.
Read the 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.
- Conditions
- Stress Hyperglycemia
- Being tested
- Dulaglutide Injection, Saline Injection
- Keywords
- Coronary Artery Bypass Surgery (CABG), Post Operative, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dulaglutide InjectionDrug
Also called Trulicity
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
Saline InjectionOther
Also called Sodium Chloride 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
| Study group | Role | What they receive |
|---|---|---|
| Dulaglutide Arm | Experimental | Participants without a history of DM who are randomized to receive a single injection of dulaglutide (0.75 mg/0.5 mL solution in a single-dose pen) one to three days prior to surgery. Receives: Drug: Dulaglutide Injection |
| Placebo Arm | Placebo comparator | Participants without a history of DM who are randomized to receive a single injection of a placebo (saline injection of 0.5 mL pre-drawn solution) one to three days prior to surgery. Receives: Other: Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period
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.
Measured: During the hospital stay (up to 12 days postoperatively)
Secondary outcomes (18)
Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay 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.
Measured: During the ICU stay (up to 7 days postoperatively)
Number of Participants Needing CII Treatment in the ICU
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.
Measured: During the ICU stay (up to 7 days postoperatively)
Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII
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.
Measured: During the hospital stay (up to 12 days postoperatively)
Mean Blood Glucose Levels During the Hospital Stay
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.
Measured: During the hospital stay (up to 12 days postoperatively)
Mean Units Per Hour of Insulin While in the ICU
The mean insulin dose during the time that participants were in the ICU is assessed as insulin infusion units per hour.
Measured: During the ICU stay (up to 7 days postoperatively)
Mean Insulin Dose Per Day While in the ICU
The mean insulin dose during the time that participants were in the ICU is assessed as insulin units per day.
Measured: During the ICU stay (up to 7 days postoperatively)
Duration of Continuous Insulin Infusion (CII)
The duration of continuous insulin infusion (CII) is assessed in hours.
Measured: During the hospital stay (up to 12 days postoperatively)
Days of Subcutaneous (SC) Insulin After Discontinuation of CII
Subcutaneous (SC) insulin use after continuous insulin infusion (CII) is discontinued is assessed as the number of days that SC insulin was required.
Measured: During the hospital stay (up to 12 days postoperatively)
Amount of SC Insulin Administered
The amount of subcutaneous (SC) insulin administered during the ICU and non-ICU hospital stay, among participants requiring SC insulin after discontinuing CII.
Measured: During the hospital stay (up to 12 days postoperatively)
Number of Participants Experiencing Hyperglycemic Events
Hyperglycemic events are defined as BG > 200 mg/dl, during ICU and non-ICU hospital stay.
Measured: During the hospital stay (up to 12 days postoperatively)
Number of Participants Experiencing Hypoglycemic Events
Hypoglycemic events are defined as BG <70, < 54, and <40 mg/dl occurring during ICU and non-ICU hospital stay.
Measured: During the hospital stay (up to 12 days postoperatively)
Number of Participants Experiencing Mortality and Complications
The number of participants experiencing a composite of mortality and complications. Complications include sternal wound infection, bacteremia, pneumonia, acute kidney injury, and acute myocardial infarction.
Measured: During the hospital stay (up to 12 days postoperatively)
Number of Participants Experiencing Gastrointestinal Adverse Events
The number participants who experienced gastrointestinal adverse events of nausea, vomiting, ileus, pancreatitis.
Measured: During the hospital stay (up to 12 days postoperatively)
ICU Length of Stay
ICU length of stay is assessed as the mean number of days participants in each study arm spent in the ICU.
Measured: During the ICU stay (up to 7 days postoperatively)
Hospital Length of Stay
Hospital length of stay is assessed as the mean number of days participants in each study arm spent in the hospital.
Measured: During the hospital stay (up to 12 days postoperatively)
Number of ICU Readmissions
The number of readmissions to the ICU.
Measured: During the hospital stay (up to 12 days postoperatively)
Number of Cerebrovascular Events
The number of cerebrovascular events.
Measured: During the hospital stay (up to 12 days postoperatively)
Participant Mortality
The number of participant deaths while in the ICU and hospital.
Measured: During the hospital stay (up to 12 days postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start8 Mar 2019
- Primary completion2 May 2023
- Study completion2 May 2023
Why it stopped: The study was terminated following the Data and Safety Monitoring Board (DSMB) review due to concerns with perioperative use of the study drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective placebo controlled randomized study
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Francisco Pasquel, Emory University
- Investigators
- Francisco Pasquel, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743025
- Sponsor's protocol ID
- IRB00097963
- Other IDs
- 1K23GM128221-01A1
- Status last verified
- May 2024
- First submitted
- 14 Nov 2018
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT03743025
- Acronym / sponsor ID
- IRB00097963
- Conditions
- Stress Hyperglycemia
- Keywords
- Coronary Artery Bypass Surgery (CABG), Post Operative, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated following the Data and Safety Monitoring Board (DSMB) review due to concerns with perioperative use of the study drug.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Posted 30 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective placebo controlled randomized study
| Arm | Type | Receives |
|---|---|---|
| Dulaglutide Arm | Experimental | Drug: Dulaglutide InjectionParticipants without a history of DM who are randomized to receive a single injection of dulaglutide (0.75 mg/0.5 mL solution in a single-dose pen) one to three days prior to surgery. |
| Placebo Arm | Placebo comparator | Other: Saline InjectionParticipants without a history of DM who are randomized to receive a single injection of a placebo (saline injection of 0.5 mL pre-drawn solution) one to three days prior to surgery. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dulaglutide InjectionAlso: TrulicityParticipants 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 Arm |
| Saline InjectionAlso: Sodium Chloride InjectionParticipants 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 | Placebo Arm |
Primary outcome
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.
18 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)
Number of Participants Needing CII Treatment in the ICU
Time frame: During the ICU stay (up to 7 days postoperatively)
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)
Mean Blood Glucose Levels During the Hospital Stay
Time frame: During the hospital stay (up to 12 days postoperatively)
Mean Units Per Hour of Insulin While in the ICU
Time frame: During the ICU stay (up to 7 days postoperatively)
Mean Insulin Dose Per Day While in the ICU
Time frame: During the ICU stay (up to 7 days postoperatively)
Duration of Continuous Insulin Infusion (CII)
Time frame: During the hospital stay (up to 12 days postoperatively)
Days of Subcutaneous (SC) Insulin After Discontinuation of CII
Time frame: During the hospital stay (up to 12 days postoperatively)
Amount of SC Insulin Administered
Time frame: During the hospital stay (up to 12 days postoperatively)
Number of Participants Experiencing Hyperglycemic Events
Time frame: During the hospital stay (up to 12 days postoperatively)
Number of Participants Experiencing Hypoglycemic Events
Time frame: During the hospital stay (up to 12 days postoperatively)
Number of Participants Experiencing Mortality and Complications
Time frame: During the hospital stay (up to 12 days postoperatively)
Number of Participants Experiencing Gastrointestinal Adverse Events
Time frame: During the hospital stay (up to 12 days postoperatively)
ICU Length of Stay
Time frame: During the ICU stay (up to 7 days postoperatively)
Hospital Length of Stay
Time frame: During the hospital stay (up to 12 days postoperatively)
Number of ICU Readmissions
Time frame: During the hospital stay (up to 12 days postoperatively)
Number of Cerebrovascular Events
Time frame: During the hospital stay (up to 12 days postoperatively)
Participant Mortality
Time frame: During the hospital stay (up to 12 days postoperatively)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Pasquel, MD, MPH principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dulaglutide Injection and Saline Injection in people with Stress Hyperglycemia, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.