The Effects of Renal Sympathetic Denervation on Insulin Sensitivity in Patients With Resistant Essential Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Insulin sensitivity expressed as an M-value
研究概览
简要总结
Renal sympathetic nerves contribute to development of hypertension. Sympathetic overactivity also induces insulin resistance and it could therefore be assumed that a renal denervation might improve insulin sensitivity. Studies have shown that glucose metabolism is improved in patients with treatment resistant essential hypertension both 1 and 3 months after renal denervation compared to a control group with treatment resistant essential hypertension. Fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance assessed by HOMA-IR. The investigators wish to investigate the effect of renal denervation on insulin sensitivity using the gold standard - the hyperinsulinemic euglycemic clamp and to investigate the degree of insulin resistance in muscle, liver and adipose tissue.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic
排除标准
- •Pregnancy
- •Non compliance
- •Heart Failure (NYHA 3-4)
- •LV ejection fraction < 50 %
- •Renal insufficiency (eGFR<30)
- •Unstable coronary heart disease
- •Coronary intervention within 6 months
- •Myocardial infarction within 6 months
- •Claudication
- •Orthostatic syncope within 6 months
- •Secondary Hypertension
- •Permanent atrial fibrillation
- •Significant Heart Valve Disease
- •Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH
- •Second and third degree heart block
- •Macroscopic haematuria
- •Proximal significant coronary stenosis
- •Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter < 4 mm, length < 2 cm, multiple renal arteries, severe calcifications)
研究组 & 干预措施
Renal denervation
The patients will be examined prior to renal denervation and 6 months after. Thus the patients are their own controls.
干预措施: Renal denervation (Procedure)
结局指标
主要结局
Insulin sensitivity expressed as an M-value
时间窗: 4 hours
To assess insulin sensitivity the hyperinsulinemic euglycemic clamp is used. The patients are given 0.8 mU/kg/min insulin as an infusion for 2 hours and the blood glucose is clamped at 5 mmol/l. For assessment of endogenous glucose production (EGP) during the glucose clamps, a tracer (3-3 H glucose) is added to the glucose infusion. The patients will be examined by the hyperinsulinemic euglycemic clamp prior to the renal denervation and 6 months after.
次要结局
- Insulin signaling(6 months)
研究者
Ulla Kampmann Opstrup
MD, PhD
University of Aarhus