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

ConditionsGlucagon-Like Peptide-1 Receptor Agonists Type 2 Diabetes Coronary Arterial Disease (CAD)

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age20+

SponsorTaipei Veterans General Hospital, Taiwan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adults (>=20 years old),

Type 2 Diabetes with coronary arterial disease underwent angioplasty within 3 months with SGLT2 inhibitors -

Disqualifiers

age<20 years old,

pregnant women,

eGFR<30 ml/min/1.73m2,

received GLP-1 agonist in the recent 3 months -

Trial design

Design model

Parallel

Treatments tested in this trial

Semaglutide 1.0 mg
Drug
add-on current standard treatment which includes SGLT2 inhibitor
Semaglutide 0.5 mg
Drug
add-on current standard treatment which includes SGLT2 inhibitor

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: semaglutide 1.0mg weeklyExperimental treatment 1 intervention

Group B: semaglutide 0.5mg weeklyActive comparator 1 intervention

Group C: controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

change of Time-in-range (%)

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.

Time frame

From enrollment to the end of treatment at 24 weeks

change of HbA1c

HbA1c at week 24 - HbA1c at baseline

Time frame

From enrollment to the end of treatment at 24 weeks

change of Flow-Mediated Dilatation (FMD)

Flow-Mediated Dilatation (FMD) at week 24 - Flow-Mediated Dilatation (FMD) at baseline

Time frame

From enrollment to the end of treatment at 24 weeks

Secondary outcomes

change of serum ROS measurements

serum ROS measurements at week 24 - serum ROS measurements at baseline

Time frame

From enrollment to the end of treatment at 24 weeks

change of Peripheral Arterial Tonometry (PAT)

Peripheral Arterial Tonometry (PAT) at week 24 - Peripheral Arterial Tonometry (PAT) at baseline

Time frame

From enrollment to the end of treatment at 24 weeks

Hypoglycemic episodes

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.

Time frame

from enrollment to the end of treatment at week 24.

change of fasting glucose

fasting glucose ar week 24 - fasting glucose at baseline

Time frame

From enrollment to the end of treatment at week 24

Other outcomes

change of serum IL-1β

levels of serum IL-1β at week 24 - levels of serum IL-1β at baseline

Time frame

From enrollment to the end of treatment at 24 weeks

change of serum IL-6

levels of serum IL-6 at week 24 - levels of serum IL-6 at baseline

Time frame

From enrollment to the end of treatment at 24 weeks

change of serum IL-10

levels of serum IL-10 at week 24 - levels of serum IL-10 at baseline

Time frame

From enrollment to the end of treatment at 24 weeks

change of serum TNF-α

levels of serum TNF-α at week 24 - levels of serum TNF-α at baseline

Time frame

From enrollment to the end of treatment at 24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei Veterans General Hospital, Taiwan

Lead sponsor

Source ClinicalTrials.gov

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