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The Effects of Renal Denervation on Insulin Sensitivity

Primary Purpose

Treatment Resistant Essential Hypertension, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Renal denervation
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Essential Hypertension

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic

Exclusion Criteria:

  • Diabetes
  • Pregnancy
  • Non compliance
  • Heart Failure (NYHA 3-4)
  • LV ejection fraction < 50 %
  • Renal insufficiency (eGFR<30)
  • Unstable coronary heart disease
  • Coronary intervention within 6 months
  • Myocardial infarction within 6 months
  • Claudication
  • Orthostatic syncope within 6 months
  • Secondary Hypertension
  • Permanent atrial fibrillation
  • Significant Heart Valve Disease
  • Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH
  • Second and third degree heart block
  • Macroscopic haematuria
  • Proximal significant coronary stenosis
  • Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter < 4 mm, length < 2 cm, multiple renal arteries, severe calcifications)

Sites / Locations

  • Medical Research Laboratories, Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal denervation

Arm Description

The patients will be examined prior to renal denervation and 6 months after. Thus the patients are their own controls.

Outcomes

Primary Outcome Measures

Insulin sensitivity expressed as an M-value
To assess insulin sensitivity the hyperinsulinemic euglycemic clamp is used. The patients are given 0.8 mU/kg/min insulin as an infusion for 2 hours and the blood glucose is clamped at 5 mmol/l. For assessment of endogenous glucose production (EGP) during the glucose clamps, a tracer (3-3 H glucose) is added to the glucose infusion. The patients will be examined by the hyperinsulinemic euglycemic clamp prior to the renal denervation and 6 months after.

Secondary Outcome Measures

Insulin signaling
Two biopsies from the lateral vastus muscle and two biopsies from the abdominal subcutaneous adipose tissue are obtained under local anesthesia. Biopsies are taken at baseline and during the clamp. Protein expression involved in the insulin signalling cascade is assessed using standard western blotting techniques.

Full Information

First Posted
June 25, 2012
Last Updated
May 1, 2018
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01631370
Brief Title
The Effects of Renal Denervation on Insulin Sensitivity
Official Title
The Effects of Renal Sympathetic Denervation on Insulin Sensitivity in Patients With Resistant Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 30, 2015 (Actual)
Study Completion Date
March 3, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Renal sympathetic nerves contribute to development of hypertension. Sympathetic overactivity also induces insulin resistance and it could therefore be assumed that a renal denervation might improve insulin sensitivity. Studies have shown that glucose metabolism is improved in patients with treatment resistant essential hypertension both 1 and 3 months after renal denervation compared to a control group with treatment resistant essential hypertension. Fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance assessed by HOMA-IR. The investigators wish to investigate the effect of renal denervation on insulin sensitivity using the gold standard - the hyperinsulinemic euglycemic clamp and to investigate the degree of insulin resistance in muscle, liver and adipose tissue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Essential Hypertension, Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal denervation
Arm Type
Experimental
Arm Description
The patients will be examined prior to renal denervation and 6 months after. Thus the patients are their own controls.
Intervention Type
Procedure
Intervention Name(s)
Renal denervation
Intervention Description
The patients are examined prior to and 6 months after renal denervation. On the day of examination the patients will have blood samples taken and the hyperinsulinemic euglycemic clamp and muscle and adipose tissue biopsies will be performed.
Primary Outcome Measure Information:
Title
Insulin sensitivity expressed as an M-value
Description
To assess insulin sensitivity the hyperinsulinemic euglycemic clamp is used. The patients are given 0.8 mU/kg/min insulin as an infusion for 2 hours and the blood glucose is clamped at 5 mmol/l. For assessment of endogenous glucose production (EGP) during the glucose clamps, a tracer (3-3 H glucose) is added to the glucose infusion. The patients will be examined by the hyperinsulinemic euglycemic clamp prior to the renal denervation and 6 months after.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Insulin signaling
Description
Two biopsies from the lateral vastus muscle and two biopsies from the abdominal subcutaneous adipose tissue are obtained under local anesthesia. Biopsies are taken at baseline and during the clamp. Protein expression involved in the insulin signalling cascade is assessed using standard western blotting techniques.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic Exclusion Criteria: Diabetes Pregnancy Non compliance Heart Failure (NYHA 3-4) LV ejection fraction < 50 % Renal insufficiency (eGFR<30) Unstable coronary heart disease Coronary intervention within 6 months Myocardial infarction within 6 months Claudication Orthostatic syncope within 6 months Secondary Hypertension Permanent atrial fibrillation Significant Heart Valve Disease Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH Second and third degree heart block Macroscopic haematuria Proximal significant coronary stenosis Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter < 4 mm, length < 2 cm, multiple renal arteries, severe calcifications)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Løgstrup, MD Dr Sci
Organizational Affiliation
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Research Laboratories, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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The Effects of Renal Denervation on Insulin Sensitivity

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