Metabolic and Cardiovascular Effects of Renal Denervation
Primary Purpose
Insulin Resistance, Hypertension
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Renal denervation using Medtronic Symplicity System (mono-electrode)
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring Renal denervation, Hypertension, Insulin resistance, Adipose tissue function
Eligibility 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
Sites / Locations
- Umeå University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
15 clinical patients undergoing renal denervation
Outcomes
Primary Outcome Measures
Adipose tissue function
Fat biopsies
Secondary Outcome Measures
Heart rate variability
Body composition
Measured by DXA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02057224
Brief Title
Metabolic and Cardiovascular Effects of Renal Denervation
Official Title
Metabolic and Cardiovascular Effects of Renal Denervation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Renal denervation has not been used as clinical method in our hospital the last two years
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 22, 2018 (Actual)
Study Completion Date
October 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Hypertension
Keywords
Renal denervation, Hypertension, Insulin resistance, Adipose tissue function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
15 clinical patients undergoing renal denervation
Intervention Type
Procedure
Intervention Name(s)
Renal denervation using Medtronic Symplicity System (mono-electrode)
Intervention Description
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 Measure Information:
Title
Adipose tissue function
Description
Fat biopsies
Time Frame
6 months after renal denervation
Secondary Outcome Measure Information:
Title
Heart rate variability
Time Frame
6 months after renal denervation
Title
Body composition
Description
Measured by DXA
Time Frame
6 months after renal denervation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Umeå University
City
Umeå
ZIP/Postal Code
90187
Country
Sweden
12. IPD Sharing Statement
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Metabolic and Cardiovascular Effects of Renal Denervation
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