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GLP-1 Receptor Agonist
Dulaglutide for Stress Hyperglycemia
Phase 4
Recruiting
Led By Georgia Davis, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women between the ages of 45 and 80 years undergoing non-cardiac general or vascular surgery with BMI ≥30 kg/m^2 without a previously known history of DM
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months after discharge
Awards & highlights
Study Summary
This trial will help determine if dulaglutide can prevent high blood sugar levels in people without diabetes who are having surgery.
Who is the study for?
This trial is for men and women aged 45-80, undergoing non-cardiac surgery with a BMI of ≥30 kg/m2, who don't have diabetes but may be at risk. It's not for those with mental conditions affecting consent, prisoners, certain gastrointestinal risks, on antihyperglycemic meds, history of specific cancers or endocrine disorders, severe kidney/liver issues, pregnant/breastfeeding individuals or those needing short hospital stays.Check my eligibility
What is being tested?
The study tests if an injectable diabetes drug (dulaglutide) can prevent high blood sugar during surgery in patients without prior diabetes. Participants will also use a continuous glucose monitor (CGM), blinded to them. Some will receive dulaglutide while others get a placebo.See study design
What are the potential side effects?
Dulaglutide could cause digestive problems like nausea or vomiting; it might also lead to inflammation of the pancreas or gallbladder disease. There's a small chance it could affect thyroid cancer risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 45-80 years old, have a BMI of 30 or more, and no known diabetes, planning to undergo surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months after discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months after discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of stress hyperglycemia (SH)
Percentage of time in target glucose range (70-140 mg/dL) by CGM
Secondary outcome measures
Baseline Insulin Secretion
Baseline Insulin Sensitivity
Change in Adiponectin Level
+25 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: DulaglutideExperimental Treatment2 Interventions
Aim 2 participants randomized to receive dulaglutide within 72 hours prior to a planned surgery.
Group II: Continuous Glucose MonitoringExperimental Treatment1 Intervention
Aim 1 participants will have a continuous glucose monitor (CGM) placed preoperatively and will wear the CGM throughout hospitalization.
Group III: PlaceboPlacebo Group2 Interventions
Aim 2 participants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dulaglutide
FDA approved
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,647 Previous Clinical Trials
2,564,396 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,201 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,378 Previous Clinical Trials
4,315,226 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am undergoing heart surgery or expected to need intensive care.I am taking steroids stronger than 5 mg of prednisone daily.I am between 45-80 years old, have a BMI of 30 or more, and have pre-diabetes or diabetes but no history of diabetes, undergoing certain surgeries.I or my family have a history of medullary thyroid cancer or MEN2.My kidney function is severely impaired, or I have significant liver failure.I understand and can consent to the study on my own.I am at high risk for or expect to have major digestive system issues.I am taking medication to lower my blood sugar.I am between 45-80 years old, have a BMI of 30 or more, and no known diabetes, planning to undergo surgery.I have issues with my stomach emptying, or have pancreatic or gallbladder disease.I will be in the hospital for less than 3 days after my surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous Glucose Monitoring
- Group 2: Placebo
- Group 3: Dulaglutide
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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