Impact of Additional Treatment With Empagliflozin or Semaglutide on Endothelial Function and Other Clinical Parameters and Biomarkers in T1DM Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery
研究概览
简要总结
The aim of study is impact of additional treatment with new antidiabetic drugs (semaglutide or empagliflozine) compared to control group in T1DM patients - impact on endothelial function measured by FMD and FPF, arterial stiffness - measured by PWV, inflammatory biomarkers, markers of oxidative stress and endothelial progenitor cells (CD 34+/VDRL2, CD 133+/VDRL2) and correlation with glucovariability or time in range, measured with CGM system.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HbA1C<=9%
- •prone to CGM system
- •20 - 70 years
排除标准
- •HbA1C >9%,
- •pregnancy or lactation,
- •known hypersensitivity to study drug,
- •malignant disease ( excluded >5 years disease free, bazocellular or planocellular ca of skin),
- •liver cirrhosis child C,
- •eGFR<60 ml/min,
- •chronic inflammatory disease,
- •proliferative diabetic rethinopathy,
- •MEN or medullary thyroid cancer in familly,
- •concomitant drugs with influence on glycemia and antiinflammatory influence (corticosteroids, immunosupresive therapy),
- •Major cardiovascular event last 2 months ( stroke, MI)
研究组 & 干预措施
GLP 1 agonist
semaglutide in titrating doses 0,25 to 1,0 mg - duration of treatment12 weeks adding to insulin sheme (MDI or CII)
干预措施: Semaglutide Pen Injector [Ozempic] (Drug)
SGLT 2 inhibitor
empagliflozin 25 mg - duration of treatment 12 weeks adding to insulin sheme (MDI or CII or hybride system)
干预措施: Empagliflozin 10 MG (Drug)
结局指标
主要结局
evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery
时间窗: 12 weeks
measurement of dilation of brachial artery (in %) before and after postishemic hyperemia comparing two therapeutic groups and control group before and after intervention
evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow
时间窗: 12 weeks
changes in tissue perfusion (ml/100 ml of tissue/min) measured with strange gauge plethysmography as formarm blood flow before and after postishemic reactive hyperemija comparing two therapeutic groups and control group before and after intervention
evaluation of arterial stiffness with peak wave velocity ( PWV)
时间窗: 12 weeks
measurements of the velocity (m/s) at which arterial blood pressure pulses propagate - comparing two therapeutic groups and control group before and after intervention
次要结局
- evaluation of change in inflammatory biomarkers(12 weeks)
- evaluation of change in biomarkers of endothelial dysfunction(12 weeks)
- evaluation of endothelial progenitor cells EPC count(12 weeks)