Renal Denervation in Diabetes.

NCT02081989 | Withdrawn Phase 4

• 2 other identifiers: CP-01/13256/13
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Diabetes; Renal denervation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Denervation

EXPERIMENTAL

Renal denervation

Procedure: Renal denervation

No intervention

NO INTERVENTION

Control group - no intervention

Interventions

Renal denervation PROCEDURE

Renal denervation

Denervation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash University: lead
• National Heart Foundation, Australia: collaborator

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Henry Krum, MBBS, FRACP, PhD

  Monash University / Alfred Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 7, 2014
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

AU (1)