The Effects of Renal Denervation on Insulin Sensitivity

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT01631370

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Treatment Resistant Essential Hypertension Insulin Resistance	Procedure: Renal denervation	N/A

Study Design

Study Type:

Interventional

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 :

Jun 1, 2012

Actual Primary Completion Date :

Mar 30, 2015

Actual Study Completion Date :

Mar 3, 2016

Arms and Interventions

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.

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

Primary Outcome Measures

Insulin sensitivity expressed as an M-value [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

Insulin signaling [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

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ulla Kampmann Opstrup, MD, PhD, University of Aarhus

ClinicalTrials.gov Identifier:

NCT01631370

Other Study ID Numbers:

UKOM20110071

First Posted:

Jun 29, 2012

Last Update Posted:

May 2, 2018

Last Verified:

Apr 1, 2015

Additional relevant MeSH terms:

Hypertension

Essential Hypertension

Insulin Resistance

Study Results

No Results Posted as of May 2, 2018