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The Effects of Renal Denervation on Insulin Sensitivity

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ClinicalTrials.gov Identifier: NCT01631370
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ulla Kampmann Opstrup, University of Aarhus

Study Description
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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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Essential Hypertension Insulin Resistance Procedure: Renal denervation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Renal Sympathetic Denervation on Insulin Sensitivity in Patients With Resistant Essential Hypertension
Study Start Date : June 2012
Actual Primary Completion Date : March 30, 2015
Actual Study Completion Date : March 3, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Renal denervation
The patients will be examined prior to renal denervation and 6 months after. Thus the patients are their own controls.
 Procedure: Renal denervation
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.


Outcome Measures
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Primary Outcome Measures :
  1. Insulin sensitivity expressed as an M-value [ Time Frame: 4 hours ]
    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 :
  1. Insulin signaling [ Time Frame: 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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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): NCT01631370


Locations
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Denmark
Medical Research Laboratories, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Per Løgstrup, MD Dr Sci Department of Endocrinology and Internal Medicine, Aarhus University Hospital
More Information
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Responsible Party: Ulla Kampmann Opstrup, MD, PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01631370    
Other Study ID Numbers: UKOM20110071
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2015
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Insulin Resistance
Vascular Diseases
 Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases