Metabolic and Cardiovascular Effects of Renal Denervation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Adipose tissue function
研究概览
简要总结
Renal denervation has recently shown to improve glucose metabolism and insulin sensitivity in addition to reducing blood pressure. The mechanisms are however unclear. The investigators hypothesize that renal denervation alters adipose tissue function by reduced sympathetic outflow, measured by fat biopsies and markers of inflammation and insulin sensitivity. 15 clinical patients undergoing renal denervation are recruited to the study investigating anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies at baseline and 6 months after renal denervation.
详细描述
Renal denervation, a catheter-based approach to reduce renal sympathetic afferent and efferent activity has been used successfully to treat drug-resistant hypertension. Previous studies has demonstrated a reduction of muscle sympathetic nerve activity and renal and total body noradrenaline spillover. In addition, renal denervation seems to improve glucose metabolism and insulin sensitivity, representing the first potential nonpharmaceutical approach for treating insulin resistance. However, the mechanisms are unclear. There is a clear relationship between sympathetic overactivity and insulin resistance. Activation of the sympathetic nervous systems contributes to insulin resistance and metabolic disorders and insulin itself induces sympathetic overactivity. One possible explanation to improved glucose metabolism after renal denervation is altered adipose tissue function (due to the reduction in sympathetic activity). Therefore,15 individuals undergoing renal denervation are recruited. The clinical study includes anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies before renal denervation and after 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Essential hypertension
- •Systolic blood pressure >160 mm Hg despite ≥3 antihypertensive drugs
- •Clinical patients accepted for renal denervation
排除标准
- •Type 1 diabetes
- •Pregnancy
- •Glomerular filtration rate ≤45 ml/min/1,73 m2
- •Pacemaker/ICD
- •Myocardial infarction/stroke the last 12 months
研究组 & 干预措施
Single arm
15 clinical patients undergoing renal denervation
干预措施: Renal denervation using Medtronic Symplicity System (mono-electrode) (Procedure)
结局指标
主要结局
Adipose tissue function
时间窗: 6 months after renal denervation
Fat biopsies
次要结局
- Heart rate variability(6 months after renal denervation)
- Body composition(6 months after renal denervation)
