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Dulaglutide for Stress Hyperglycemia
Study Summary
This trial will help determine if dulaglutide can prevent high blood sugar levels in people without diabetes who are having surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Continuous Glucose Monitoring
- Group 2: Placebo
- Group 3: Dulaglutide
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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