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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 without known history of diabetes with ages between 45 and 80 years undergoing non-cardiac general or vascular surgery participating in Aim 1 with BMI ≥30 kg/m2 and pre-DM or DM by OGTT or HbA1c
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
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 below
Select...
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.
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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 weeks
Treatment ~ Varies
Follow Up ~up to 3 months after discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months after discharge for reporting.

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 more

Trial 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
1,636 Previous Clinical Trials
2,560,328 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,334 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,314,941 Total Patients Enrolled

Media Library

Dulaglutide (GLP-1 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04862234 — Phase 4
Stress Hyperglycemia Research Study Groups: Continuous Glucose Monitoring, Placebo, Dulaglutide
Stress Hyperglycemia Clinical Trial 2023: Dulaglutide Highlights & Side Effects. Trial Name: NCT04862234 — Phase 4
Dulaglutide (GLP-1 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04862234 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper cap of participants involved in this experiment?

"Affirmative. The information available at clinicaltrials.gov specifies that this medical experiment is actively enrolling individuals, which was first announced on July 29th 2021 and was last updated the same day. It seeks to recruit 245 members from two separate sites."

Answered by AI

Who is qualified to partake in this medical experiment?

"This clinical trial requires 245 individuals aged 45 to 80 with hyperglycemia. Of particular note, the required criteria are: BMI ≥30 kg/m2 and no prior diagnosis of diabetes mellitus (DM), male or female participants between 45-80 years undergoing non-cardiac general or vascular surgery in Aim 1., and an additional requirement of either pre-diabetes by OGTT or HbA1c for those without known history of DM also participating in Aim 1."

Answered by AI

What are the primary aims of this investigation?

"The primary aim of this trial, which is expected to be completed within two weeks (depending on hospital stay duration), is to measure the prevalence of stress hyperglycemia. Secondary indicators that will also be observed include number and percentage of transfers from ICU in SH patients, frequency of hypoglycaemia events under a glucose level below 40 mg/dL, as well as length of hospitalisation for those with or without SH."

Answered by AI

Has the Continuous Glucose Monitor been granted blind approval by the FDA?

"Our team at Power has determined that the safety of Continuous Glucose Monitor (CGM) technology, when used in a blinded fashion, is highly reliable based on its Phase 4 status; this treatment option is already approved."

Answered by AI

What medical reason is the Continuous Glucose Monitor (CGM) typically utilized for?

"The use of a Continuous glucose monitor (CGM) has been demonstrated to effectively manage type 2 diabetes mellitus, reduce cardiovascular risk factors, and adjust dietary habits."

Answered by AI

Are there any available slots remaining in this clinical trial?

"Affirmative. Clinicaltrials.gov indicates that this investigation, which was inaugurated on July 29th 2021, is actively seeking out patients to join their team of 245 individuals from 2 different medical sites."

Answered by AI

Is there a minimum age requirement for participation in the research study?

"This clinical trial requests applicants between the ages of 45 and 80. For those outside this age range, 4 separate studies are available for under 18s and over 65s respectively."

Answered by AI
~69 spots leftby May 2025