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GLP-1 Agonist
Liraglutide for Coronary Heart Disease
Phase 4
Recruiting
Led By Gianluca Iacobellis, MD PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
T2DM as defined by American Diabetes Association (ADA) criteria
Adult patients with T2DM who are indicated to receive liraglutide, not as first-line therapy, in addition to diet and exercise to improve glycemic control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from a minimum of 4 weeks up to 12 weeks
Awards & highlights
Study Summary
This trial will test whether the anti-diabetic medication liraglutide can reduce the risk of cardiovascular disease by reducing inflammation in the Epicardial Adipose Tissue (EAT).
Who is the study for?
This trial is for adults over 18 with stable coronary artery disease requiring bypass surgery and type 2 diabetes, with a BMI ≥27 or waist circumference ≥102 cm in men and ≥88 cm in women. Participants should have an HbA1c ≤9% and be on a stable diabetes regimen but not first-line therapy. Exclusions include those with serious hypersensitivity to liraglutide, pregnant or breastfeeding women, unstable CAD, certain other medical conditions, or using specific medications.Check my eligibility
What is being tested?
The study tests if the drug Liraglutide can reduce inflammation in heart fat tissue among patients with type 2 diabetes and coronary artery disease undergoing bypass surgery. It's a randomized double-blind trial comparing Liraglutide against placebo over at least four weeks before surgery to see its effect on inflammatory genes within epicardial adipose tissue.See study design
What are the potential side effects?
Liraglutide may cause side effects such as digestive issues (nausea, vomiting), potential pancreatitis risk, allergic reactions including rash or swelling of face/throat, thyroid tumors including cancer (rare), increased heart rate, kidney problems which might require dialysis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with type 2 diabetes.
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I have type 2 diabetes and my doctor recommends liraglutide, not as my first treatment, to help control my blood sugar.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from a minimum of 4 weeks up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from a minimum of 4 weeks up to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
EAT inflammation
Secondary outcome measures
EAT GLP-1R
EAT thickness
SAT inflammation
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: L-groupActive Control1 Intervention
• L-group will be started on liraglutide. Liraglutide will be started and administered for from a minimum of 4 weeks up to 12 weeks prior to CABG with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). The dose of 1.8 mg daily will be maintained until the end of the 12-week study. Other and current diabetes treatment will be continued
Group II: D-groupPlacebo Group1 Intervention
placebo will be administered in addition to current treatment prior to the CABG with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). D-group will be started on a supervised low calorie diet (LCD) to achieve approximately 5% of weight loss after from a minimum of 4 weeks up to 12 weeks.
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Who is running the clinical trial?
University of MiamiLead Sponsor
902 Previous Clinical Trials
410,036 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
585 Patients Enrolled for Coronary Artery Disease
Novo Nordisk A/SIndustry Sponsor
1,514 Previous Clinical Trials
2,415,028 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
2,000 Patients Enrolled for Coronary Artery Disease
Gianluca Iacobellis, MD PhD4.98 ReviewsPrincipal Investigator - University of Miami
University of Miami
2 Previous Clinical Trials
80 Total Patients Enrolled
5Patient Review
This doctor is excellent!!
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using birth control as required.I am currently taking medication for diabetes that is not a fast-acting insulin.You have recently developed severe chest pain that is getting worse quickly.I have a chronic or acute inflammatory condition like asthma or rheumatoid arthritis.I have a history of medullary thyroid cancer or MEN2 in my family or myself.I have been diagnosed with type 2 diabetes.I have type 2 diabetes and my doctor recommends liraglutide, not as my first treatment, to help control my blood sugar.My heart disease is stable and I need a bypass surgery, which is safe with liraglutide.I have a history of serious health issues, including diabetes complications, organ transplants, or major organ diseases.I have not taken any corticosteroids in the last 3 months.I have no health conditions that make liraglutide unsafe for me.You had a severe allergic reaction to liraglutide before.I am 18 years old or older.Your hemoglobin A1c level is less than or equal to 9%.You have type 1 diabetes according to the American Diabetes Association's criteria.You have a high body mass index (BMI) or waist circumference measurement.
Research Study Groups:
This trial has the following groups:- Group 1: L-group
- Group 2: D-group
Awards:
This trial has 2 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What indications might necessitate the use of L-group medications?
"L-group can be employed to assist with cardio risk minimisation, physical fitness and reducing the impact of single drug therapy."
Answered by AI
Is this research study still recruiting participants?
"As detailed by clinicaltrials.gov, the enrollment for this medical trial is now open to participants. The study was first made available on September 1st 2018 and underwent its most recent edit in November 4th 2022."
Answered by AI
Could you provide a tally of participants in this research study?
"Correct. Recent information from clinicaltrials.gov confirms that this research is still seeking participants, having first been posted on September 1st 2018 and revised as recently as November 4th 2022. 40 persons need to be recruited at a single site."
Answered by AI
Are there any potential health risks associated with using L-group medications?
"There is a considerable amount of data that attests to the safety of L-group, resulting in it receiving a score of 3. This Phase 4 trial confirms its approval as an effective treatment option."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
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