The Effects of Renal Denervation on Insulin Sensitivity

Insulin Resistance Clinical Trial

Official title:

The Effects of Renal Sympathetic Denervation on Insulin Sensitivity in Patients With Resistant Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631370
• Other study ID #: UKOM20110071
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: March 3, 2016

Study information

• Verified date: April 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 3, 2016
• Est. primary completion date: March 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Insulin Resistance
• Treatment Resistant Essential Hypertension

Intervention

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.

Locations

Country	Name	City	State
Denmark	Medical Research Laboratories, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 hours
Secondary	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.	6 months