The Effects of Renal Denervation on Insulin Sensitivity

NCT ID: NCT01631370

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-03-03

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.

Conditions

Treatment Resistant Essential Hypertension; Insulin Resistance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal denervation

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

Group Type: EXPERIMENTAL

Renal denervation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Ulla Kampmann Opstrup

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Per Løgstrup, MD Dr Sci

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Locations

Medical Research Laboratories, Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

UKOM20110071

Identifier Type: -

Identifier Source: org_study_id