Renal Denervation in Diabetes.

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02081989
• Other study ID #: CP-01/13
• Secondary ID: 256/13
• Status: Withdrawn
• Phase: Phase 4
• First received: March 6, 2014
• Last updated: May 30, 2016
• Start date: November 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Procedure:
• Renal denervation
Renal denervation

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Monash University	National Heart Foundation, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control	Change in glycemic control at 6 months.	6 months	No
Primary	glucose uptake into peripheral skeletal muscle	To assess glucose uptake into peripheral skeletal muscle	6 months	No