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临床试验/NCT07073053
NCT07073053尚未招募4 期

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

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
change of Time-in-range (%)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

semaglutide 1.0mg weekly

Experimental

continue previous standard treatment with add-on semaglutide

干预措施: Semaglutide 1.0 mg (Drug)

semaglutide 0.5mg weekly

Active Comparator

continue previous standard treatment with add-on semaglutide

干预措施: Semaglutide 0.5 mg (Drug)

结局指标

主要结局

change of Time-in-range (%)

时间窗: 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

时间窗: From enrollment to the end of treatment at 24 weeks

HbA1c at week 24 - HbA1c at baseline

change of Flow-Mediated Dilatation (FMD)

时间窗: From enrollment to the end of treatment at 24 weeks

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

次要结局

  • change of serum ROS measurements(From enrollment to the end of treatment at 24 weeks)
  • change of Peripheral Arterial Tonometry (PAT)(From enrollment to the end of treatment at 24 weeks)
  • Hypoglycemic episodes(from enrollment to the end of treatment at week 24.)
  • change of fasting glucose(From enrollment to the end of treatment at week 24)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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