Actively Recruiting
GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM
Led by Federico II University · Updated on 2026-01-02
80
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Type II diabetes mellitus (T2DM) is a chronic disease associated with a very high risk of developing cardiovascular (CV) events, especially because of its long-term effects. Glucagon-like-peptide-1 receptor agonists (GLP1-RAs) are recommended in subjects suffering from T2DM with a history or at risk for CV disease; however there is a lack of evidence on local actions of GLP1-RAs on inflammation and endothelial function. The STABLE-GLP1 study aims to evaluate, in patients with T2DM without atherosclerotic cardiovascular disease (ASCVD) or severe target-organ damage (TOD), the possible beneficial effect of semaglutide, a GLP1-AR, on clinical prognosis, inflammatory and endothelial biomarkers. The STABLE-GLP1 trial is a phase IV interventional, national, multicenter, randomized, pragmatic study, aiming at enrolling 80 patients with T2DM and no ASCVD. Participants will be randomized in 1:1 ratio to receive semaglutide in addition to standard therapy or standard therapy alone, according to body mass index (BMI) category (BMI \<30 vs. ≥30 kg/m²). All patients will perform clinical visit, ECG, echocardiography, blood sample collection for endothelial and inflammatory biomarkers dosage at baseline, at 26 weeks, and after 52 weeks of treatment. Data from CTA, performed according to clinical practice before enrollment, will be recorded and retrospectively evaluated to test secondary outcomes.
CONDITIONS
Official Title
GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of T2DM without ASCVD or severe target-organ damage but with SCORE2-Diabetes �3E�3D 10% and clinical indication to start semaglutide therapy
- Pre-randomization coronary CT angiography showing no stenosis �3E�3D 50% in epicardial coronary vessels within 2 years before enrollment
- Stable clinical conditions with controlled blood pressure, lipid profile, and blood sugar levels within 4 weeks before enrollment
- Stable antidiabetic treatment for at least 6 weeks
- Left ventricular ejection fraction 50% or higher
- For female participants: not pregnant or lactating and of non-childbearing potential confirmed by menopause or irreversible surgical sterilization
- Ability to understand study procedures and provide consent
You will not qualify if you...
- Age over 85 years
- Previous treatment with semaglutide or other GLP1 receptor agonists
- Stenosis of epicardial coronary arteries 50% or greater
- Kidney function with eGFR less than 45 mL/min/1.73 m2 or moderate impairment with microalbuminuria or proteinuria or microvascular disease in at least three sites
- History of any clinically important disease that may increase risk or affect ability to participate
- Any history of atherosclerotic cardiovascular disease
- Ongoing severe heart failure (New York Heart Association Class IV)
- Significant valve disease of the heart
- Type 1 diabetes mellitus
- Allergy to semaglutide or any excipients
- Known or suspected liver disease with elevated liver enzymes
- Acute inflammatory or infectious disease within 3 months before enrollment
- Chronic inflammatory, immune, or infectious diseases
- History of cancer within the past 5 years
- History of alcohol, drug, or medication abuse
- Exposure to other types of medical or professional radiation
- Clinically relevant blood disorders
- Uncontrolled metabolic disorders
- Recent alcohol or drug abuse within 3 months
AI-Screening
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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
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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