Metabolic and Cardiovascular Effects of Renal Denervation

NCT ID: NCT02057224

Last Updated: 2019-08-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-10-22

Brief Summary

Renal denervation has recently shown to improve glucose metabolism and insulin sensitivity in addition to reducing blood pressure. The mechanisms are however unclear. The investigators hypothesize that renal denervation alters adipose tissue function by reduced sympathetic outflow, measured by fat biopsies and markers of inflammation and insulin sensitivity. 15 clinical patients undergoing renal denervation are recruited to the study investigating anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies at baseline and 6 months after renal denervation.

Detailed Description

Renal denervation, a catheter-based approach to reduce renal sympathetic afferent and efferent activity has been used successfully to treat drug-resistant hypertension. Previous studies has demonstrated a reduction of muscle sympathetic nerve activity and renal and total body noradrenaline spillover. In addition, renal denervation seems to improve glucose metabolism and insulin sensitivity, representing the first potential nonpharmaceutical approach for treating insulin resistance. However, the mechanisms are unclear. There is a clear relationship between sympathetic overactivity and insulin resistance. Activation of the sympathetic nervous systems contributes to insulin resistance and metabolic disorders and insulin itself induces sympathetic overactivity. One possible explanation to improved glucose metabolism after renal denervation is altered adipose tissue function (due to the reduction in sympathetic activity). Therefore,15 individuals undergoing renal denervation are recruited. The clinical study includes anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies before renal denervation and after 6 months.

Conditions

Insulin Resistance; Hypertension

Study Design

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

Study Groups

Single arm

15 clinical patients undergoing renal denervation

Group Type: EXPERIMENTAL

Renal denervation using Medtronic Symplicity System (mono-electrode)

Intervention Type: PROCEDURE

Secondary hypertension is excluded by an extensive preoperative clinical investigation and the renal artery anatomy is visualized by computer tomography (with contrast). By cannulating the femoral artery both renal arteries are treated by a radiofrequency-catheter, 4-6 ablations in each artery.

Interventions

Renal denervation using Medtronic Symplicity System (mono-electrode)

Secondary hypertension is excluded by an extensive preoperative clinical investigation and the renal artery anatomy is visualized by computer tomography (with contrast). By cannulating the femoral artery both renal arteries are treated by a radiofrequency-catheter, 4-6 ablations in each artery.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Essential hypertension
• Systolic blood pressure >160 mm Hg despite ≥3 antihypertensive drugs
• Clinical patients accepted for renal denervation

Exclusion Criteria

• Type 1 diabetes
• Pregnancy
• Glomerular filtration rate ≤45 ml/min/1,73 m2
• Pacemaker/ICD
• Myocardial infarction/stroke the last 12 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Jonas Andersson

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Umeå University

Umeå, , Sweden

Countries

Sweden

Other Identifiers

joan2014

Identifier Type: -

Identifier Source: org_study_id