2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes.
Nikolaus Marx, Massimo Federici, Katharina Schütt...
https://pubmed.ncbi.nlm.nih.gov/37622663Actively Recruiting
Phase 4
Age: 18Years - 85Years
All Genders
ID07314684
Impact of GLP1-RAs on Inflammation and Endothelial biomarkerS in Type 2 diABetes meLlitus patiEnts: STABLE-GLP1 Trial
Led by Federico II University · Updated on 2026-01-02
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of semaglutide, a glucagon-like-peptide-1 receptor agonist (GLP1-RA), on inflammation and endothelial function in people with type 2 diabetes mellitus (T2DM) who do not have atherosclerotic cardiovascular disease or severe organ damage. This phase IV, randomized controlled trial aims to understand semaglutide's impact on clinical outcomes and biomarkers linked to heart health in patients with T2DM and an elevated cardiovascular risk score. In this study, 80 participants with T2DM will be randomly assigned to receive either semaglutide added to their standard diabetes treatment or their usual standard therapy alone. Semaglutide dosing will start at 0.25 mg once weekly and may be increased up to 1 mg weekly based on glycemic control. The standard therapy may include various diabetes medications such as Biguanides, Insulins, or SGLT2 inhibitors. The treatment period lasts 52 weeks, with assessments at baseline, 26 weeks, and 52 weeks. Participants will also have prior coronary CT angiography data reviewed to explore heart vessel characteristics. During the trial, participants will undergo clinical visits including ECG and echocardiography, as well as blood tests to measure inflammatory and endothelial biomarkers at set intervals. Researchers will monitor safety and tolerability of semaglutide compared to standard therapy. The main outcomes focus on changes in inflammation and endothelial function biomarkers after one year of treatment. Data from previous coronary imaging will also be analyzed in relation to biomarkers and major cardiovascular events. The study will help clarify semaglutide's role in managing cardiovascular risk in T2DM.
CONDITIONS
Brief Title
GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older.
- Diagnosis of type 2 diabetes mellitus without atherosclerotic cardiovascular disease or severe target-organ damage but with SCORE2-Diabetes 9%.
- Available coronary CT angiography performed within 2 years showing no stenosis 50% in epicardial coronary vessels.
- Stable clinical conditions with controlled blood pressure, lipid profile, and blood sugar levels assessed within 4 weeks before inclusion.
- Stable antidiabetic treatment for at least 6 weeks.
- Left ventricular ejection fraction of 50% or higher.
- Female participants must not be pregnant or breastfeeding and must be confirmed as non-childbearing by menopause or irreversible sterilization.
- Ability to understand the study and provide informed consent.
You will not qualify if you...
- Age over 85 years.
- Previous use of semaglutide or other GLP1 receptor agonists.
- Presence of stenosis 50% or greater in epicardial coronary arteries.
- Kidney function below 45 mL/min/1.73 m2 or moderate kidney issues with microalbuminuria or proteinuria.
- History of any clinically important disease that may increase risk or affect participation.
- Any history of atherosclerotic cardiovascular disease.
- Severe heart failure (NYHA Class IV) or significant valve disease.
- Diagnosis of type 1 diabetes mellitus.
- Allergy to semaglutide or its ingredients.
- Known or suspected liver disease with high liver enzyme levels.
- Recent acute or chronic inflammatory or infectious diseases.
- History of cancer within the last 5 years.
- History of alcohol, drug, or medication abuse.
- Recent exposure to radiation or professional hazards.
- Blood disorders or metabolic disorders that are not controlled.
- Alcohol or drug abuse in the past 3 months.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 52 weeks
Participants receive semaglutide in addition to standard therapy or standard therapy alone to manage type 2 diabetes and evaluate effects on inflammatory and endothelial biomarkers.
Weekly visits for dose administration and monitoring
Trial Site Locations
Total: 2 locations
1
Azienda Ospedaliera Sant'Anna e San Sebastiano
Caserta, Caserta, Italy, 81100
Actively Recruiting
2
Federico II University
Naples, Napoli, Italy, 80131
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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