DiabetesPhase 4NCT02081989
Renal Denervation in Diabetes.
A Phase 4 study testing Renal denervation in people with Diabetes, run by Monash University at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Renal denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2015to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Renal Sympathetic Denervation on Glycemic Status Independent of Blood Pressure-lowering.
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
- Being tested
- Renal denervation
- Keywords
- Diabetes, Renal denervation
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervationProcedure or surgery
Renal denervation
| Study group | Role | What they receive |
|---|---|---|
| Denervation | Experimental | Renal denervation Receives: Procedure: Renal denervation |
| No intervention | No intervention | Control group - no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Change in glycemic control at 6 months.
Measured: 6 months
glucose uptake into peripheral skeletal muscle
To assess glucose uptake into peripheral skeletal muscle
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Unable to commence study due to closure of hospital department.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart Foundation, Australia
- Responsible party
- Principal investigator, Ingrid Hopper, Monash University
- Investigators
- Henry Krum, MBBS, FRACP, PhD, Principal investigator, Monash University / Alfred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081989
- Sponsor's protocol ID
- CP-01/13
- Other IDs
- 256/13
- Status last verified
- May 2016
- First submitted
- 6 Mar 2014
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Renal Sympathetic Denervation on Glycemic Status Independent of Blood Pressure-lowering.
- ClinicalTrials.gov ID
- NCT02081989
- Acronym / sponsor ID
- CP-01/13
- Conditions
- Diabetes
- Keywords
- Diabetes, Renal denervation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to commence study due to closure of hospital department.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- National Heart Foundation, Australia
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denervation | Experimental | Procedure: Renal denervationRenal denervation |
| No intervention | No intervention | –Control group - no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal denervationRenal denervation | Procedure or surgery | Denervation |
Primary outcome
Glycemic control
Time frame: 6 months
Change in glycemic control at 6 months.
glucose uptake into peripheral skeletal muscle
Time frame: 6 months
To assess glucose uptake into peripheral skeletal muscle
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Krum, MBBS, FRACP, PhD principal investigator
Monash University / Alfred Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Renal denervation in people with Diabetes, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.