Glucagon-Like Peptide-1 Receptor Agonists, Type 2 Diabetes, Coronary Arterial Disease (CAD)
Conditions
Keywords
Glucagon-Like Peptide-1 Receptor Agonists, type 2 diabetes, coronary arterial disease
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.
Interventions
add-on current standard treatment which includes SGLT2 inhibitor
add-on current standard treatment which includes SGLT2 inhibitor
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| change of HbA1c | From enrollment to the end of treatment at 24 weeks | HbA1c at week 24 - HbA1c at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| change of serum IL-10 | From enrollment to the end of treatment at 24 weeks | levels of serum IL-10 at week 24 - levels of serum IL-10 at baseline |
| change of serum IL-6 | From enrollment to the end of treatment at 24 weeks | levels of serum IL-6 at week 24 - levels of serum IL-6 at baseline |
| change of urinary 8-iso PGF 2alfa | From enrollment to the end of treatment at 24 weeks | urinary 8-iso PGF 2alfa at week 24 - urinary 8-iso PGF 2alfa at baseline |
| change of serum TNF-α | From enrollment to the end of treatment at 24 weeks | levels of serum TNF-α at week 24 - levels of serum TNF-α at baseline |
| change of serum IL-1β | From enrollment to the end of treatment at 24 weeks | levels of serum IL-1β at week 24 - levels of serum IL-1β at baseline |
Countries
Taiwan
Contacts
Primary ContactChin-Sung Kuo, M.D., Ph.D.
Outcome results
None listed