Renal Sympathetic Denervation in Metabolic Syndrome (Metabolic Syndrome Study)

Abbott Medical Devices1 site in 1 country20 target enrollmentSeptember 2014

ConditionsMetabolic Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metabolic Syndrome
Sponsor: Abbott Medical Devices
Enrollment: 20
Locations: 1
Primary Endpoint: Change in insulin resistance from baseline to 3 months after renal denervation
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical investigation is to determine the effects of renal sympathetic denervation on insulin resistance and muscle sympathetic nerve activity in patients with metabolic syndrome.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

June 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient with office blood pressure ≥140/90 mmHg and 24-hour ambulatory blood pressure ≥130/80 mmHg at Baseline despite the stable use of at least two anti-hypertensive drugs at maximum tolerated doses of the patient for at least 4 weeks
•Patient with a fasting glucose ≥100 mg/dL (≥5.6 mmol/L) at Baseline or on drug treatment for elevated glucose
•Patient with a waist circumference ≥102 cm (≥40 inches) for male or ≥88 cm (≥35 inches) for female at Baseline
•Patient with any of the remaining two metabolic syndrome diagnostic criteria listed as follows at Baseline
•Triglycerides ≥150 mg/dL (≥1.7 mmol/L) or on drug treatment for elevated triglycerides
•High density lipid cholesterol (HDL-C) \<40 mg/dL (\<1.03 mmol/L) for male or \<50 mg/dL (\<1.30 mmol/L) for female or on drug treatment for reduced HDL-C
•Patient is ≥18 and ≤70 years old
•Patient must be able and willing to provide written informed consent to participate in this clinical investigation
•Patient must be able and willing to comply with the required follow-up schedule

Exclusion Criteria

•Patient with secondary hypertension
•Patient with type I diabetes mellitus or type II diabetes mellitus requiring insulin therapy
•Patient with prior renal angioplasty, renal denervation, indwelling renal stents and/or aortic stent grafts
•Patient with renal arteries \<4.0 mm in diameter
•Patient with significant renovascular abnormalities (such as renal artery stenosis \>30%)
•Patient with an estimated glomerular filtration rate (eGFR) of \<45 mL/min per 1.73 m2 using the Modified Diet in Renal Disease (MDRD) formula
•Patient with hemodynamically significant valvular heart disease, as determined by Study Investigator
•Patient has had a myocardial infarction, unstable angina pectoris or cerebrovascular accident less than 180 days at Baseline or is expected to have cardiovascular intervention within the next 180 days
•Patient is in chronic atrial fibrillation/flutter or with severe conduction abnormalities or with an implantable cardioverter defibrillator (ICD) or pacemaker whose settings cannot allow for radiofrequency (RF) energy delivery
•Patient is currently being treated with drugs that cause salt retention (such as systemic corticosteroids or fludrocortisone), centrally acting sympatholytic antihypertensive drugs, direct vasodilators (such as alpha blockers) and continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea

Outcomes

Primary Outcomes

Change in insulin resistance from baseline to 3 months after renal denervation

Time Frame: Baseline and Month 3

To determine the effects of renal sympathetic denervation on insulin resistance (determined by the Homeostasis Model Assessment - Insulin Resistance method) at 3 months after renal denervation

Change in muscle sympathetic nerve activity (MSNA) from baseline to 3 months after renal denervation

Time Frame: Baseline and Month 3

To determine the effects of renal sympathetic denervation on MSNA at 3 months after renal denervation

Secondary Outcomes

Change in insulin resistance from baseline to 12 months after renal denervation(Baseline and Month 12)
Change in muscle sympathetic nerve activity (MSNA) from baseline to 12 months after renal denervation(Baseline and Month 12)