Role of Adrenaline in the Inflammatory Response in People with Diabetes Mellitus Type 1, and Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Monocyte count
研究概览
简要总结
The primary aim of the present study is to study the effect of adrenaline administration on inflammatory parameters (e.g. leukocyte phenotype, cytokines, inflammatory proteins). Secondary objectives consist of the effect of adrenaline on atherogenic parameters.
- All participants will receive intravenous infusion of adrenaline for an hour
- We will draw blood at 7 time points, not including screening
- Participants will be asked to return for a total of 4 times
Researchers will compare 2 groups, healthy individuals versus people with diabetes type 1 to see if the inflammatory reaction to adrenaline differs between these two groups.
详细描述
Objective
The aim of the present study is to study the effect of increased adrenaline levels on the inflammatory response (e.g. leukocyte phenotype, cytokines, inflammatory proteins) by administering exogenous adrenaline in participants with type 1 diabetes and healthy participants.
Potentially eligible adult ( 16 - 75 years) participants will be recruited from the diabetes clinic at the department of internal medicine from the Radboud University Medical Center. Healthy participants will be recruited through social media and other advertisements. We will recruit a total of 30 individuals, i.e. 15 healthy participants and 15 people with type 1 diabetes. Participants with type 1 diabetes will be equipped with a blinded continuous glucose monitoring device (CGM) during the test, which will measure interstitial glucose levels for a total of 10 days.
Intervention: All participants will receive intravenous infusion of adrenaline at a rate of 0.04ug/kg/min for 1 hour. We will draw blood at baseline, 30 minutes, 60 minutes, 180 minutes, 24 hours 72 hours and a week after start of infusion. The blood samples will be used for phenotyping of the innate immune system and measuring inflammatory and atherogenic parameters. Throughout the infusion, vital parameters will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Any event of cardiovascular disease in the past 5 years (e.g. myocardial infarction, stroke, heart failure, symptomatic peripheral arterial disease)
- •Pregnancy or breastfeeding or unwillingness to undertake measures for birth control
- •Current treatment with Alpha or beta blockers ( doxazosin, propranolol)
- •History of panic disorders
- •History of Arrhythmias
- •Use of immune-modifying drugs or antibiotics
- •Use of tricyclic antidepressants or MAO inhibitors
- •Use of statins (e.g. stop statins >2 weeks before performing blood sampling.
- •Any infection with systemic symptoms in past 2 weeks
- •Previous vaccination in the past 2 weeks
- •Proliferative retinopathy
- •Nephropathy with an estimated glomerular filtration rate (by MDRD) ˂60ml/min/1.73m2
研究组 & 干预措施
People with type 1 diabetes
The participants with type 1 diabetes will receive an intravenous infusion of adrenaline at a rate of 0.04ug/kg/min for 1 hour.
干预措施: Adrenaline (Drug)
Healthy individuals
The participants without type 1 diabetes will receive an intravenous infusion of adrenaline at a rate of 0.04ug/kg/min for 1 hour.
干预措施: Adrenaline (Drug)
结局指标
主要结局
Monocyte count
时间窗: Change from baseline compared to after 1 hour
The amount of monocytes following 60 minutes of adrenaline infusion compared to baseline to asses the adrenaline effect on the inflammatory response.
次要结局
- Leukocyte count(Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion)
- Glucose variability(2 weeks)
- Inflammation plasma parameters(Change from baseline at 30, 60 and 180 minutes day 1, day 3 and day 7 after adrenaline infusion)
- Insulin(Change from baseline at, 60 and 180 minutes)
- Ex vivo cytokines(Change from baseline at 30, 60 and 180 minutes, day 1, day 3 and day 7 after adrenaline infusion)
- Noradrenaline(Change from baseline at 30, 60 and 180 minutes)
- Atherogenic parameters(Change from baseline at 30, 60 and 180 minutes day 1, day 3 and day 7 after adrenaline infusion)
- Leukocyte phenotype(Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion)
- Pro-inflammatory proteins(Change from baseline at day 30, 60 and 180 minutes 1, day 3 and day 7 after adrenaline infusion)
- Adrenaline(Change from baseline at 30, 60 and 180 minutes)
- Distribution of monocyte subset(Change from baseline at 30, 60 and 180 minutes, day 1, day 3 and day 7 after adrenaline infusion)
研究者
Cees Tack
Prof. Dr.
Radboud University Medical Center