Metabolic and Cardiovascular Effects of Renal Denervation

Umeå University

Status: Terminated

Conditions: Hypertension; Insulin Resistance

Treatments: Procedure: Renal denervation using Medtronic Symplicity System (mono-electrode)

Study type: Interventional

Funder types: Other

Identifiers

NCT02057224

joan2014

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Single arm

Experimental group

Description:

15 clinical patients undergoing renal denervation

Treatment:

Procedure: Renal denervation using Medtronic Symplicity System (mono-electrode)