Renal Denervation in Diabetes.

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Effect of Renal Sympathetic Denervation on Glycemic Status Independent of Blood Pressure-lowering.

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Procedure: Renal denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Denervation<br>Renal denervation | Procedure: Renal denervation<br>* Renal denervation<br>|
| No Intervention: No intervention<br>Control group - no intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Change in glycemic control at 6 months. | 6 months | 
| glucose uptake into peripheral skeletal muscle | To assess glucose uptake into peripheral skeletal muscle | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Renal denervation