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Metabolic and Cardiovascular Effects of Renal Denervation

Metabolic and Cardiovascular Effects of Renal Denervation

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02057224
Enrollment
5
Registered
2014-02-07
Start date
2014-01-31
Completion date
2018-10-22
Last updated
2019-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Insulin Resistance

Keywords

Renal denervation, Hypertension, Insulin resistance, Adipose tissue function

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.

Interventions

PROCEDURERenal 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.

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adipose tissue function6 months after renal denervationFat biopsies

Secondary

MeasureTime frameDescription
Heart rate variability6 months after renal denervation
Body composition6 months after renal denervationMeasured by DXA

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026