Metabolic and Cardiovascular Effects of Renal Denervation

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Umeå University
Sponsor:
Information provided by (Responsible Party):
Jonas Andersson, Umeå University
ClinicalTrials.gov Identifier:
NCT02057224
First received: January 29, 2014
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Insulin Resistance
Hypertension
Procedure: Renal denervation using Medtronic Symplicity System (mono-electrode)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic and Cardiovascular Effects of Renal Denervation

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Adipose tissue function [ Time Frame: 6 months after renal denervation ] [ Designated as safety issue: No ]
    Fat biopsies


Secondary Outcome Measures:
  • Heart rate variability [ Time Frame: 6 months after renal denervation ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 6 months after renal denervation ] [ Designated as safety issue: No ]
    Measured by DXA


Estimated Enrollment: 15
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057224

Locations
Sweden
Umeå University Recruiting
Umeå, Sweden, 90187
Contact: Jonas Andersson, MD, PhD    +46705515618    jonas.andersson@medicin.umu.se   
Principal Investigator: Jonas Andersson, MD, PhD         
Sponsors and Collaborators
Umeå University
  More Information

No publications provided

Responsible Party: Jonas Andersson, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT02057224     History of Changes
Other Study ID Numbers: joan2014
Study First Received: January 29, 2014
Last Updated: February 5, 2014
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish Data Inspection Board

Keywords provided by Umeå University:
Renal denervation
Hypertension
Insulin resistance
Adipose tissue function

Additional relevant MeSH terms:
Hypertension
Insulin Resistance
Cardiovascular Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014