Metabolic and Cardiovascular Effects of Renal Denervation

• Sponsor: Umeå University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02057224
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 57.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance; Hypertension	Procedure: Renal denervation using Medtronic Symplicity System (mono-electrode)	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Metabolic and Cardiovascular Effects of Renal Denervation
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Oct 22, 2018
• Actual Study Completion Date: Oct 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm 15 clinical patients undergoing renal denervation	Procedure: Renal denervation using Medtronic Symplicity System (mono-electrode); 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.

Outcome Measures

Primary Outcome Measures

1. Adipose tissue function [6 months after renal denervation]

   Fat biopsies

Secondary Outcome Measures

1. Heart rate variability [6 months after renal denervation]

2. Body composition [6 months after renal denervation]

   Measured by DXA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Umeå University	Umeå		Sweden	90187

Sponsors and Collaborators

• Umeå University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonas Andersson, MD, PhD, Umeå University
• ClinicalTrials.gov Identifier: NCT02057224
• Other Study ID Numbers: joan2014
• First Posted: Feb 7, 2014
• Last Update Posted: Aug 12, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Jonas Andersson, MD, PhD, Umeå University: Renal denervation; Hypertension; Insulin resistance; Adipose tissue function
• Additional relevant MeSH terms: Hypertension; Insulin Resistance

Study Results

No Results Posted as of Aug 12, 2019