Denervation of the REnal Artery in Metabolic Syndrome (DREAMS)
The current prevalence of hypertension as part of the metabolic syndrome is substantial and is increasing with the rise of obesity worldwide. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a common and key factor in disease states as obesity-related hypertension (ORH). The renal sympathetic nerves are a major contributor to the complex pathophysiology of this elevated SNS activity. Percutaneous renal denervation (PRDN), the deliberate disruption of the nerves connecting the kidneys with the central nervous system, has been shown to be an effective means of modulating elevated SNS activity.
This current study is an observational feasibility study, with the aim to investigate the effect of renal denervation on changes in insulin resistance and blood pressure in patients with obesity related hypertension. The investigators will study different variables: a laboratorial set, a set of blood pressure measurements and a set of investigations in the vascular laboratory.
- The investigators hypothesize that renal denervation has a beneficial effect on insulin resistance.
- The investigators hypothesize that there will be no complications related to the device or procedure.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sympathetic Denervation of the Renal Artery for the Treatment of Obesity-related Hypertension and Insulin Resistance|
- Difference in Insulin resistance before and 12 months after renal denervation [ Time Frame: T=0, T=6 months, and t=12 months ] [ Designated as safety issue: No ]To investigate the influence of percutaneous renal sympathetic denervation on insulin resistance. Hereby evaluating an Oral Glucose Tolerance Test before and after renal denervation
- Difference in blood pressure before and after renal denervation [ Time Frame: t=0, t=6 months, and t=12 months ] [ Designated as safety issue: No ]
- Safety [ Time Frame: one year ] [ Designated as safety issue: Yes ]Major adverse events, characterized by myocardial infarction, cerebrovascular accident or all-cause mortality.
- Fasting glucose before and after renal denervation [ Time Frame: t=0 and t=12 months ] [ Designated as safety issue: No ]
- Change in Muscle sympathetic nerve activity (MSNA)after renal denervation [ Time Frame: t=0 and t=6 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
|Experimental: Renal denervation||
Procedure: Renal denervation
percutaneous selective renal sympathetic denervation with the use of the Symplicity Catheter system.
Other Name: Symplicity Catheter system
Objectives: The objectives of this study are: to compare changes in insulin resistance in patients with ORH after RDN; to evaluate the safety of PRDN in this patient group; to compare changes in blood pressure, laboratory parameters, arterial stiffness and SNS-activity after PRDN.
Study design: Prospective observational feasibility-study.
Study population: Patients with a high fasting glucose (fasting serum glucose ≥5.6 mmol/L(100 mg/dL)) and with an ambulatory systolic blood pressure >130mmHg.
Major endpoints: The effect of RDN on: insulin resistance, blood pressure and major adverse events.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465724
|Principal Investigator:||Michiel Voskuil, MD, PhD||UMC Utrecht|
|Principal Investigator:||Willemien Verloop, MD||UMC Utrecht|