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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation Group | Other | Subjects receiving renal denervation procedure. |
|
| Control Group | No Intervention | Subjects not receiving renal denervation procedure. Subjects are randomized in a 3:1 ratio to either Renal Denervation Group or Control Group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation | Procedure | Renal artery ablation with the EnligHTN™ Renal Denervation System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin resistance from baseline to 3 months after renal denervation | 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 | Baseline and Month 3 |
| Change in muscle sympathetic nerve activity (MSNA) from baseline to 3 months after renal denervation | To determine the effects of renal sympathetic denervation on MSNA at 3 months after renal denervation | Baseline and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin resistance from baseline to 12 months after renal denervation | To determine the effects of renal sympathetic denervation on insulin resistance long-term (12 months after renal denervation). | Baseline and Month 12 |
| Change in muscle sympathetic nerve activity (MSNA) from baseline to 12 months after renal denervation |
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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
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hippocration Hospital, University of Athens | Athens | Greece |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| EnligHTN™ Renal Denervation System. | Device |
|
To determine the effects of renal sympathetic denervation on MSNA long-term (12 months after renal denervation). |
| Baseline and Month 12 |
| D009750 |
| Nutritional and Metabolic Diseases |