Taipei Veterans General Hospital
Taipei, 112, Taiwan
NCT Number: NCT07073053
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.
Trial opening soon.
Get Notified20 year and older
All sexes
Interventional
Phase 4
Taipei, 112, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
add-on current standard treatment which includes SGLT2 inhibitor
add-on current standard treatment which includes SGLT2 inhibitor
Time frame: 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.
Time frame: From enrollment to the end of treatment at 24 weeks
HbA1c at week 24 - HbA1c at baseline
Time frame: From enrollment to the end of treatment at 24 weeks
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
serum ROS measurements at week 24 - serum ROS measurements at baseline
Time frame: From enrollment to the end of treatment at 24 weeks
Peripheral Arterial Tonometry (PAT) at week 24 - Peripheral Arterial Tonometry (PAT) at baseline
Time frame: 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.
Time frame: From enrollment to the end of treatment at week 24
fasting glucose ar week 24 - fasting glucose at baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Taipei Veterans General Hospital, Taiwan
Other Gov
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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