Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Metabolic and Cardiovascular Effects of Renal Denervation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057224
Recruitment Status : Terminated (Renal denervation has not been used as clinical method in our hospital the last two years)
First Posted : February 7, 2014
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Jonas Andersson, Umeå University

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) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : January 2014
Actual Primary Completion Date : October 22, 2018
Actual Study Completion Date : October 22, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Adipose tissue function [ Time Frame: 6 months after renal denervation ]
    Fat biopsies


Secondary Outcome Measures :
  1. Heart rate variability [ Time Frame: 6 months after renal denervation ]
  2. Body composition [ Time Frame: 6 months after renal denervation ]
    Measured by DXA



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057224


Locations
Layout table for location information
Sweden
Umeå University
Umeå, Sweden, 90187
Sponsors and Collaborators
Umeå University
Layout table for additonal information
Responsible Party: Jonas Andersson, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT02057224    
Other Study ID Numbers: joan2014
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Keywords provided by Jonas Andersson, Umeå University:
Renal denervation
Hypertension
Insulin resistance
Adipose tissue function
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Insulin Resistance
Vascular Diseases
Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases