跳至主要内容
临床试验/NCT02057224
NCT02057224终止不适用

Metabolic and Cardiovascular Effects of Renal Denervation

Umeå University2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2014年1月最近更新:
适应症
干预措施

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

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

Experimental

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonas Andersson

MD, PhD

Umeå University

研究点 (2)

Loading locations...

相似试验