Renal Denervation in Diabetes.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-05-31

Brief Summary

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Renal denervation (the use of radio waves to oblate the renal artery) has been shown to be an effective treatment for high blood pressure. It is currently being tested in heart failure patients and we would now like to look it its effects on diabetes.

We therefore plan to enrol 20 participants with type II diabetes into this study. Half will undergo renal denervation in addition to their standard care and the other half will act as controls and only receive standard care. Treatment allocation will be randomly assigned.

All participants will undergo screening (including a physical exam, blood tests, ultrasounds and a muscle biopsy). All patients will have follow up tests (including physical exams and blood tests) 1, 3 and 6 months later.

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Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Denervation

Renal denervation

Group Type EXPERIMENTAL

Renal denervation

Intervention Type PROCEDURE

Renal denervation

No intervention

Control group - no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Renal denervation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Over 18 years
* Able and willing to provide informed consent
* Patients with established type II diabetes mellitus (HbA1C\>7%, diet or oral hypoglycaemic agents)
* Clinical stable as demonstrated by no change in background anti-diabetic medication in the last 30 days.
* Anticipated that patients are able to maintain a stable dose of medication for the duration of the study

Exclusion Criteria

* Renal arterial anatomy ineligible for RDN: main renal arteries \<4 mm in diameter or \<20 mm in treatable length; multiple renal arteries where main renal artery is estimated to supply \<75% of the kidney; haemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the investigator's opinion, would interfere with safe cannulation of the renal artery or require surgical repair or interventional dilation
* History of prior renal artery intervention including balloon angioplasty, stenting or previous renal denervation.
* Single functioning kidney
* Need for insulin (interferes with euglycemic clamp testing) or GLP-I analogues
* eGFR \<30 ml/min (MDRD formula)
* Any medical condition which, in the investigators opinion, may adversely affect the participants safety in the trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No