NCT02057224

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2018

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

4.8 years

First QC Date

January 29, 2014

Last Update Submit

August 8, 2019

Conditions

Insulin ResistanceHypertension

Keywords

Renal denervationHypertensionInsulin resistanceAdipose tissue function

Outcome Measures

Primary Outcomes (1)

  • Adipose tissue function

    Fat biopsies

    6 months after renal denervation

Secondary Outcomes (2)

  • Heart rate variability

    6 months after renal denervation

  • Body composition

    6 months after renal denervation

Study Arms (1)

Single arm

EXPERIMENTAL

15 clinical patients undergoing renal denervation

Procedure: Renal denervation using Medtronic Symplicity System (mono-electrode)

Interventions

Renal denervation using Medtronic Symplicity System (mono-electrode)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.

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University

Umeå, 90187, Sweden

Location

MeSH Terms

Conditions

Insulin ResistanceHypertension

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 29, 2014

First Posted

February 7, 2014

Study Start

January 1, 2014

Primary Completion

October 22, 2018

Study Completion

October 22, 2018

Last Updated

August 12, 2019

Record last verified: 2019-08

Locations

SE(1)