Effect of Renal Sympathetic Denervation on Glycemic Status Independent of Blood Pressure-lowering.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Glycemic control
研究概览
简要总结
Renal denervation (the use of radio waves to oblate the renal artery) has been shown to be an effective treatment for high blood pressure. It is currently being tested in heart failure patients and we would now like to look it its effects on diabetes.
We therefore plan to enrol 20 participants with type II diabetes into this study. Half will undergo renal denervation in addition to their standard care and the other half will act as controls and only receive standard care. Treatment allocation will be randomly assigned.
All participants will undergo screening (including a physical exam, blood tests, ultrasounds and a muscle biopsy). All patients will have follow up tests (including physical exams and blood tests) 1, 3 and 6 months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Over 18 years
- •Able and willing to provide informed consent
- •Patients with established type II diabetes mellitus (HbA1C>7%, diet or oral hypoglycaemic agents)
- •Clinical stable as demonstrated by no change in background anti-diabetic medication in the last 30 days.
- •Anticipated that patients are able to maintain a stable dose of medication for the duration of the study
排除标准
- •Renal arterial anatomy ineligible for RDN: main renal arteries <4 mm in diameter or <20 mm in treatable length; multiple renal arteries where main renal artery is estimated to supply <75% of the kidney; haemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the investigator's opinion, would interfere with safe cannulation of the renal artery or require surgical repair or interventional dilation
- •History of prior renal artery intervention including balloon angioplasty, stenting or previous renal denervation.
- •Single functioning kidney
- •Need for insulin (interferes with euglycemic clamp testing) or GLP-I analogues
- •eGFR <30 ml/min (MDRD formula)
- •Any medical condition which, in the investigators opinion, may adversely affect the participants safety in the trial
研究组 & 干预措施
Denervation
Renal denervation
干预措施: Renal denervation (Procedure)
No intervention
Control group - no intervention
结局指标
主要结局
Glycemic control
时间窗: 6 months
Change in glycemic control at 6 months.
glucose uptake into peripheral skeletal muscle
时间窗: 6 months
To assess glucose uptake into peripheral skeletal muscle
次要结局
未报告次要终点
研究者
Ingrid Hopper
Senior Lecturer
Monash University