Renal Denervation in Diabetes. | NCT02081989

Studies
Renal Denervation in Diabetes.

NCT02081989

Sponsor

Monash University

Status

Withdrawn

Last Update Posted

Jun 1, 2016Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Diabetes

Interventions

Renal denervation

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
256/13	Other Identifier	Alfred Hospital

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to commence study due to closure of hospital department.

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Mar 6, 2014

First Submission Date that Met QC Criteria

Mar 6, 2014

First Posted Date

Mar 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2016

Last Update Posted Date

Jun 1, 2016Estimated

Name	Class
National Heart Foundation, Australia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Denervation	Experimental	Renal denervation	Procedure: Renal denervation
No intervention	No Intervention	Control group - no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renal denervation	Procedure	Renal denervation	Denervation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Henry Krum, MBBS, FRACP, PhD	Monash University / Alfred Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Alfred Hospital		Melbourne	Victoria	3004	Australia

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided