Effect of Rapid Glucose Excursion Versus Continuous Glucose Infusion on Cardiovascular and Metabolic Parameters in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Interleukin-6
研究概览
简要总结
The effects of rapid glucose excursions, induced by intravenous bolus application of glucose in healthy probands, on cardiometabolic and inflammatory parameters will be investigated
详细描述
BACKGROUND: It is well known that people with diabetes have a five times higher risk of dying of cardiovascular death than non-diabetics. However not only hyperglycaemia per se but also glycaemic variability is currently particularly regarded as a risk factor for cardiovascular and microvascular complications. Intermittent blood sugar excursions with pronounced fluctuations between high and low values instead of constant, even increased blood sugar exposure, have been shown to be more harmful in several studies.
AIM: The aim of this study is to determine the effect of rapid glucose excursion versus continuous glucose infusion on cardiovascular and metabolic parameters in healthy volunteers.
METHODS/DESIGN: In this study, ten healthy male subjects will be studied on two occasions. In a random order the subjects will receive 3 times 20 grams of glucose intravenously as a bolus or, on the other occasion, 60 grams of glucose continuously over 3 hours. Cardiometabolic biomarkers will be analysed serially to analyse the effects of glucose excursions.
PROSPECT: Glycaemic variability may be a crucial factor in the development of diabetic complications, but there is currently a lack of conclusive evidence. The causes and mechanisms of these negative influences on the cardiovascular system due to high glucose variability have not been sufficiently investigated and are therefore not fully understood so far. To date, however, there have been no studies with acutely altered glucose concentrations in healthy volunteers that have investigated the effects on traditional as well as recently identified cardiovascular and metabolic biomarkers. Knowledge of such effects may improve the therapeutic strategy in diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 18 years or older with no disease history
- •written informed consent
排除标准
- •receiving any medication
- •probands who suffer from infectious disease
结局指标
主要结局
Interleukin-6
时间窗: 48 hours
measurement of the concentration of IL-6 (parameter of inflammation) in the serum over time following infusion
次要结局
未报告次要终点
