The Role of Glucagon-Like Peptide-1 Receptor Agonists in Coronary Artery Diseases and Their Potential Mechanisms

Not Applicable

Not yet recruiting

• Conditions: Glucagon-Like Peptide-1 Receptor Agonists; Type 2 Diabetes; Coronary Arterial Disease (CAD)
• Interventions: Drug: Semaglutide 1.0 mg; Drug: Semaglutide 0.5 mg

• Registration Number: NCT07073053
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-16
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Study Start: 2025-10-01
• Primary Completion: 2028-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. adults (>=20 years old),
2. Type 2 Diabetes with coronary arterial disease underwent angioplasty within 3 months with SGLT2 inhibitors -

Exclusion Criteria

1. age<20 years old,
2. pregnant women,
3. eGFR<30 ml/min/1.73m2,
4. received GLP-1 agonist in the recent 3 months -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
semaglutide 1.0mg weekly	Semaglutide 1.0 mg	continue previous standard treatment with add-on semaglutide
semaglutide 0.5mg weekly	Semaglutide 0.5 mg	continue previous standard treatment with add-on semaglutide

Primary Outcome Measures

Name	Time	Method
change of Time-in-range (%)	From enrollment to the end of treatment at 24 weeks	continuous glucose monitor, time-in-range defined as percentage of time in range of 70-180 blood glucose levels. Change of time-in-range means time-in-range at week 24 - time-in-range at baseline.
change of HbA1c	From enrollment to the end of treatment at 24 weeks	HbA1c at week 24 - HbA1c at baseline
change of Flow-Mediated Dilatation (FMD)	From enrollment to the end of treatment at 24 weeks	Flow-Mediated Dilatation (FMD) at week 24 - Flow-Mediated Dilatation (FMD) at baseline

Secondary Outcome Measures

Name	Time	Method
change of serum ROS measurements	From enrollment to the end of treatment at 24 weeks	serum ROS measurements at week 24 - serum ROS measurements at baseline
change of Peripheral Arterial Tonometry (PAT)	From enrollment to the end of treatment at 24 weeks	Peripheral Arterial Tonometry (PAT) at week 24 - Peripheral Arterial Tonometry (PAT) at baseline
Hypoglycemic episodes	from enrollment to the end of treatment at week 24.	the amount of hypoglycemic episodes during the treatment period of 24 weeks. hypoglycemic episodes defined as blood sugar levels less than 50 or with hypoglycemic symptoms.
change of fasting glucose	From enrollment to the end of treatment at week 24	fasting glucose ar week 24 - fasting glucose at baseline

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan