Renal Denervation in Diabetes.

Phase 4WithdrawnNCT02081989

Monash University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Diabetes

Interventions

Renal denervationPROCEDURE

Renal denervation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Alfred Hospital

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Glycemic control

Change in glycemic control at 6 months.

Time frame: 6 months

glucose uptake into peripheral skeletal muscle

To assess glucose uptake into peripheral skeletal muscle

Time frame: 6 months

Data from ClinicalTrials.gov

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