Metabolic and Cardiovascular Effects of Renal Denervation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Metabolic and Cardiovascular Effects of Renal Denervation

Conditions
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Insulin Resistance, Hypertension

Intervention / Treatment
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* Procedure: Renal denervation using Medtronic Symplicity System (mono-electrode)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Essential hypertension Systolic blood pressure >160 mm Hg despite ≥3 antihypertensive drugs Clinical patients accepted for renal denervation Exclusion Criteria: Type 1 diabetes Pregnancy Glomerular filtration rate ≤45 ml/min/1,73 m2 Pacemaker/ICD Myocardial infarction/stroke the last 12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>15 clinical patients undergoing renal denervation | Procedure: Renal denervation using Medtronic Symplicity System (mono-electrode)<br>* Secondary hypertension is excluded by an extensive preoperative clinical investigation and the renal artery anatomy is visualized by computer tomography (with contrast). By cannulating the femoral artery both renal arteries are treated by a radiofrequency-catheter, 4-6 ablations in each artery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adipose tissue function | Fat biopsies | 6 months after renal denervation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability |  | 6 months after renal denervation | 
| Body composition | Measured by DXA | 6 months after renal denervation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal denervation, Hypertension, Insulin resistance, Adipose tissue function