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The Effects of Renal Denervation on Insulin Sensitivity

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ulla Kampmann Opstrup, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01631370
First received: June 25, 2012
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Treatment Resistant Essential Hypertension
Insulin Resistance
 Procedure: Renal denervation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Renal Sympathetic Denervation on Insulin Sensitivity in Patients With Resistant Essential Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Insulin sensitivity expressed as an M-value [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 8
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631370

Locations
Denmark
Medical Research Laboratories, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Per Løgstrup, MD Dr Sci Department of Endocrinology and Internal Medicine, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Ulla Kampmann Opstrup, MD, PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01631370     History of Changes
Other Study ID Numbers: UKOM20110071
Study First Received: June 25, 2012
Last Updated: January 21, 2013
Health Authority: Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013