The Effects of Iloprost Infusion on Capillary Recruitment and Whole-body Glucose Uptake in Type 2 Diabetic Patients - a Cross-over Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Rate of disappearance
研究概览
简要总结
This study examines the effects of iloprost - a stable prostacyclin analogue - on insulin-mediated muscle capillary recruitment and whole-body glucose uptake in a cross-over design.
详细描述
In type 2 diabetes impaired insulin-mediated muscle perfusion is thought to contribute to reduced whole-body glucose uptake. This study aims to identify iloprost - a stable prostacyclin analogue - as a possible therapeutic option to increase whole-body glucose uptake via enhancement of muscle perfusion.
All participants will be subjected to two hyperinsulinemic-euglycemic clamps; one with and one without simultaneous iloprost infusion in a randomized cross-over design. Microvascular blood volume will be measured by means of contrast-enhanced ultrasonography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Male or female (post-menopausal)
- •Age above 45 years and below 70 years
- •BMI >30 kg/m2
- •HbA1c < 80 mmol/mol or < 8,6% Subjects must use metformin
- •Stable medication use
- •Stable tension regulation (with or without medication)
- •Subjects should be able to give informed consent
排除标准
- •A history of cardiovascular event (Cerebrovascular event, myocardial infarction or pacemaker implantation)
- •Severe-very severe lung emphysema (GOLD stage III-IV)
- •Use of any antibiotics or proton pump inhibitor (PPI) in the past three months
- •Use of any other antidiabetic medication besides metformin (e.g. SU-derivates, insulin)
- •Use of a platelet inhibitor or cumarin derivate during
- •Subjects participated in a lifestyle programme in the past 6 months (diet or exercise)
研究组 & 干预措施
Iloprost first
Cross-over starts with iloprost intervention, then second clamp without iloprost.
干预措施: Iloprost infusion (Drug)
Iloprost second
Cross-over starts without iloprost intervention, then second clamp with iloprost.
干预措施: Iloprost infusion (Drug)
结局指标
主要结局
Rate of disappearance
时间窗: During the clamp
Glucose uptake in peripheral tissues during hyperinsulinemic euglycemic clamp
Capillary recruitment
时间窗: Before and during the clamp
Change in skeletal muscle en myocardial microvascular blood volume upon insulin infusion
次要结局
- Continous cardiovascular monitoring(Before and during the clamp)
研究者
Erik Serne
Principal Investigator
Amsterdam UMC, location VUmc