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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| semaglutide 1.0mg weekly | Experimental | continue previous standard treatment with add-on semaglutide |
|
| semaglutide 0.5mg weekly | Active Comparator | continue previous standard treatment with add-on semaglutide |
|
| control | No Intervention | continue previous standard treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide 1.0 mg | Drug | add-on current standard treatment which includes SGLT2 inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 24 weeks |
| change of HbA1c | HbA1c at week 24 - HbA1c at baseline | 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 | From enrollment to the end of treatment at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change of serum ROS measurements | serum ROS measurements at week 24 - serum ROS measurements at baseline | From enrollment to the end of treatment at 24 weeks |
| change of Peripheral Arterial Tonometry (PAT) |
| Measure | Description | Time Frame |
|---|---|---|
| change of serum IL-1β | levels of serum IL-1β at week 24 - levels of serum IL-1β at baseline | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chin-Sung Kuo, M.D., Ph.D. | Contact | +886-2-28757513 | cskuo@vghtpe.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
The IPD share plan was not mentioned in this patient consent form.
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| Semaglutide 0.5 mg | Drug | add-on current standard treatment which includes SGLT2 inhibitor |
|
Peripheral Arterial Tonometry (PAT) at week 24 - Peripheral Arterial Tonometry (PAT) at baseline
| 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. | from enrollment to the end of treatment at week 24. |
| change of fasting glucose | fasting glucose ar week 24 - fasting glucose at baseline | From enrollment to the end of treatment at week 24 |
| 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 | 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 | From enrollment to the end of treatment at 24 weeks |
| change of urinary 8-iso PGF 2alfa | urinary 8-iso PGF 2alfa at week 24 - urinary 8-iso PGF 2alfa at baseline | From enrollment to the end of treatment at 24 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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