The Role of Glucagon-Like Peptide-1 Receptor Agonists in Coronary Artery Diseases and Their Potential Mechanisms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide 1.0 mg, Semaglutide 0.5 mg.
- Who it may be relevant to
- Registry conditions: Glucagon-Like Peptide-1 Receptor Agonists, Type 2 Diabetes, Coronary Arterial Disease (CAD). Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The investigators plan to enroll 60 patients from the outpatient clinics or inpatient wards of the Metabolism and Cardiology departments who, within the past three months, have undergone coronary angiography for the treatment of coronary artery disease, are currently using sodium-glucose cotransporter-2 (SGLT-2) inhibitors for glycemic control, and have not received glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy for more than three months. A randomized controlled clinical trial will be conducted, with 20 participants randomly assigned to receive semaglutide (a GLP-1 RA) at 1 mg once weekly for 6 months, another 20 participants to receive semaglutide at 0.5 mg once weekly for 6 months, and the control group (20 participants) to continue with standard treatment for 6 months. The effects after 6 months will be evaluated in terms of endothelial function, glycemic control indicators including glycemic variability assessed via continuous glucose monitoring (CGM), oxidative stress markers, and the incidence of symptomatic hypoglycemia. According to the treatment guidelines for type 2 diabetes, either GLP-1 receptor agonists or SGLT-2 inhibitors should be prioritized in patients with type 2 diabetes and coronary artery disease. Therefore, the medication choices in both the intervention and control groups in this study align with current treatment guidelines.
Interventions
- Drug Semaglutide 1.0 mg
add-on current standard treatment which includes SGLT2 inhibitor - Drug Semaglutide 0.5 mg
add-on current standard treatment which includes SGLT2 inhibitor
Primary outcome measures
- change of Time-in-range (%) [Time frame: From enrollment to the end of treatment at 24 weeks]
- change of HbA1c [Time frame: From enrollment to the end of treatment at 24 weeks]
- change of Flow-Mediated Dilatation (FMD) [Time frame: From enrollment to the end of treatment at 24 weeks]
Secondary outcome measures (4)
- change of serum ROS measurements [Time frame: From enrollment to the end of treatment at 24 weeks]
- change of Peripheral Arterial Tonometry (PAT) [Time frame: From enrollment to the end of treatment at 24 weeks]
- Hypoglycemic episodes [Time frame: from enrollment to the end of treatment at week 24.]
- change of fasting glucose [Time frame: From enrollment to the end of treatment at week 24]
Eligibility criteria
Inclusion criteria
- adults (>=20 years old),
- Type 2 Diabetes with coronary arterial disease underwent angioplasty within 3 months with SGLT2 inhibitors -
Exclusion criteria
- age<20 years old,
- pregnant women,
- eGFR<30 ml/min/1.73m2,
- received GLP-1 agonist in the recent 3 months -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taipei Veterans General Hospital — Taipei
Identifiers
NCT: NCT07073053 · 2025-02-004C