Renal Denervation in Diabetes.

Monash University

Status and phase

Withdrawn

Phase 4

Conditions

Diabetes

Treatments

Procedure: Renal denervation

Study type

Interventional

Funder types

Other

Identifiers

NCT02081989

CP-01/13

256/13 (Other Identifier)

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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