The Effects of Renal Denervation on Insulin Sensitivity

University of Aarhus

Status: Completed

Conditions: Insulin Resistance; Treatment Resistant Essential Hypertension

Treatments: Procedure: Renal denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT01631370

UKOM20110071

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Renal denervation

Experimental group

Description:

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

Treatment:

Procedure: Renal denervation