The Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination on Endothelial Function, Arterial Stiffness and Left Ventricular Deformation in Patients With Type 2 Diabetes With High Cardiovascular Risk
Study on Diabetes Drugs' Heart Effects
Plain English Summary
The Cardiovascular Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination is a Not Applicable clinical trial sponsored by University of Athens studying Diabetes Mellitus, Type 2. This study tests how two types of diabetes medications (GLP-1 agonists and SGLT2 inhibitors), alone and together, affect the heart and blood vessels. It is for adults with Type 2 diabetes who are at high risk for heart problems or have a specific type of heart failure. Participation involves being assigned to one of four treatment groups and having regular check-ups and tests over 12 months. Alternatives include standard diabetes care and other medications not specifically studied here. The trial aims to enroll 240 participants.
Official Summary
A. Four groups of patients with type 2 diabetes mellitus with high or very high cardiovascular risk or heart failure with preserved ejection fraction (HFpEF) will be studied before and at 6 and 12 months of treatment: * 60 patients treated with a combination of GLP1 analogue and SGLT2 inhibitor ± metformin * 60 patients treated with GLP-1 agonist as a second step after metformin * 60 patients treated with SGLT2 inhibitor as a second step after metformin * 60 patients treated with a combination of insulin and other antidiabetic agents (metformin - DPP4 inhibitors) Individuals will be equal distributed as far as age, gender and body mass index concerned. In addition, patients suffered from kidney disease and retinopathy are excluded.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have Type 2 diabetes and are at high risk for heart disease or have heart failure with preserved ejection fraction. You cannot join if you have Type 1 diabetes, kidney disease, or eye problems (retinopathy). Age and body mass index will be considered to ensure balanced groups. This trial is studying Diabetes Mellitus, Type 2, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The study will measure how well the heart muscle squeezes (Global Longitudinal Strain) over 12 months to see if the treatments improve heart function. The specific primary outcome measures are: Comparison of Global Longitudinal Strain (GLS) difference among treatment groups. (12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it investigates how new diabetes medications can protect the heart in a high-risk population, addressing a gap in understanding their cardiovascular benefits. This research targets Diabetes Mellitus, Type 2, where improved treatment options are needed.
Investor Insight
This observational study focuses on understanding the cardiovascular effects of existing diabetes medications, suggesting potential for improved patient outcomes and informing future treatment guideli
Is This Trial Right for Me?
Ask your doctor if these medications are right for you and what the potential benefits and risks are. Participation involves regular visits for tests and monitoring of your diabetes and heart health over a year. You will be assigned to one of four treatment groups, receiving either a combination of drugs, or one of the drugs, or standard care with other diabetes medications. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 240 participants
Primary Outcomes
- Comparison of Global Longitudinal Strain (GLS) difference among treatment groups. (12 months)
Secondary Outcomes
- Comparison of arterial stiffness markers difference among treatment groups. (12 months)
- Comparison of wave reflection markers difference among treatment groups (12 months)
- Comparison of central aortic blood pressure differences among treatment groups (12 months)
- Comparison of endothelial glycocalyx thickness difference among treatment groups (12 months)
- Comparison of oxidative stress and endothelial function biomarkers differences among treatment groups (12 months)
Full Eligibility Criteria
Inclusion Criteria: * Subject has type 2 diabetes mellitus * Subject has high or very high cardiovascular risk * Subject has heart failure with preserved ejection fraction Exclusion Criteria: * Subject has type 1 diabetes mellitus * Subject has kidney disease * Subject has retinopathy
Trial Locations
- "Attikon" University General Hospital, Athens, Attica, Greece
Frequently Asked Questions
What is clinical trial NCT03878706?
NCT03878706 is a Not Applicable OBSERVATIONAL study titled "The Cardiovascular Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination." It is currently recruiting and is sponsored by University of Athens. The trial targets enrollment of 240 participants.
What conditions does NCT03878706 study?
This trial investigates treatments for Diabetes Mellitus, Type 2. The primary condition under study is Diabetes Mellitus, Type 2.
What does Not Applicable mean for NCT03878706?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT03878706?
This trial is currently "Recruiting." It started on 2017-11-03. The estimated completion date is 2027-06-30.
Who is sponsoring NCT03878706?
NCT03878706 is sponsored by University of Athens. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT03878706?
The trial aims to enroll 240 participants. The trial is currently recruiting and accepting new participants.
How is NCT03878706 designed?
This is a observational study.
What are the primary outcomes being measured in NCT03878706?
The primary outcome measures are: Comparison of Global Longitudinal Strain (GLS) difference among treatment groups. (12 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT03878706 being conducted?
This trial is being conducted at 1 site, including Athens, Attica (Greece).
Where can I find official information about NCT03878706?
The official record for NCT03878706 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT03878706. This government database provides the most up-to-date and detailed information about the trial.
What is NCT03878706 testing in simple terms?
This study tests how two types of diabetes medications (GLP-1 agonists and SGLT2 inhibitors), alone and together, affect the heart and blood vessels. It is for adults with Type 2 diabetes who are at high risk for heart problems or have a specific type of heart failure.
Why is this trial significant?
This trial is important because it investigates how new diabetes medications can protect the heart in a high-risk population, addressing a gap in understanding their cardiovascular benefits.
What are the potential risks of participating in NCT03878706?
Potential side effects of GLP-1 agonists can include nausea, vomiting, and diarrhea. SGLT2 inhibitors may increase the risk of urinary tract infections and yeast infections. Some individuals may experience changes in blood sugar levels or other less common side effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT03878706?
Ask your doctor if these medications are right for you and what the potential benefits and risks are. Participation involves regular visits for tests and monitoring of your diabetes and heart health over a year. You will be assigned to one of four treatment groups, receiving either a combination of drugs, or one of the drugs, or standard care with other diabetes medications. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT03878706 signal from an investment perspective?
This observational study focuses on understanding the cardiovascular effects of existing diabetes medications, suggesting potential for improved patient outcomes and informing future treatment guideli This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves being assigned to one of four treatment groups and having regular check-ups and tests over 12 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
- Diabetes Mellitus, Type 2
- Cardiovascular Risk
- Heart Failure with Preserved Ejection Fraction (HFpEF)
- Arterial Stiffness
- Endothelial Dysfunction
- Metabolic Syndrome
- Obesity
- Hypertension
- Diabetic Nephropathy (patients with kidney disease are excluded from this study)
- Diabetic Retinopathy (patients with retinopathy are excluded from this study)
More Diabetes Mellitus, Type 2 Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.