Insulin ResistanceNCT02057224
Metabolic and Cardiovascular Effects of Renal Denervation
A study testing Renal denervation using Medtronic Symplicity System (mono-electrode) in people with Insulin Resistance and Hypertension, run by Umeå University at 1 site in Sweden.
Trial summary
Renal denervation has recently shown to improve glucose metabolism and insulin sensitivity in addition to reducing blood pressure. The mechanisms are however unclear. The investigators hypothesize that renal denervation alters adipose tissue function by reduced sympathetic outflow, measured by fat biopsies and markers… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin Resistance, Hypertension
- What is being tested?
- Renal denervation using Medtronic Symplicity System (mono-electrode)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2014to 22 Oct 2018
- Phase
- Interventional
- 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
- Essential hypertension
- Systolic blood pressure >160 mm Hg despite ≥3 antihypertensive drugs
- Clinical patients accepted for renal denervation
Who cannot join
- Type 1 diabetes
- Pregnancy
- Glomerular filtration rate ≤45 ml/min/1,73 m2
- Pacemaker/ICD
- Myocardial infarction/stroke the last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Renal denervation has recently shown to improve glucose metabolism and insulin sensitivity in addition to reducing blood pressure. The mechanisms are however unclear. The investigators hypothesize that renal denervation alters adipose tissue function by reduced sympathetic outflow, measured by fat biopsies and markers of inflammation and insulin sensitivity. 15 clinical patients undergoing renal denervation are recruited to the study investigating anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies at baseline and 6 months after renal denervation.
Read the detailed description
Renal denervation, a catheter-based approach to reduce renal sympathetic afferent and efferent activity has been used successfully to treat drug-resistant hypertension. Previous studies has demonstrated a reduction of muscle sympathetic nerve activity and renal and total body noradrenaline spillover. In addition, renal denervation seems to improve glucose metabolism and insulin sensitivity, representing the first potential nonpharmaceutical approach for treating insulin resistance. However, the mechanisms are unclear. There is a clear relationship between sympathetic overactivity and insulin resistance. Activation of the sympathetic nervous systems contributes to insulin resistance and metabolic disorders and insulin itself induces sympathetic overactivity. One possible explanation to improved glucose metabolism after renal denervation is altered adipose tissue function (due to the reduction in sympathetic activity). Therefore,15 individuals undergoing renal denervation are recruited. The clinical study includes anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies before renal denervation and after 6 months.
- Conditions
- Insulin Resistance, Hypertension
- Being tested
- Renal denervation using Medtronic Symplicity System (mono-electrode)
- Keywords
- Renal denervation, Hypertension, Insulin resistance, Adipose tissue function
- Medical subject headings
- Insulin Resistance, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervation using Medtronic Symplicity System (mono-electrode)Procedure or surgery
Secondary hypertension is excluded by an extensive preoperative clinical investigation and the renal artery anatomy is visualized by computer tomography (with contrast). By cannulating the femoral artery both renal arteries are treated by a radiofrequency-catheter, 4-6 ablations in each artery.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | 15 clinical patients undergoing renal denervation Receives: Procedure: Renal denervation using Medtronic Symplicity System (mono-electrode) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue function
Fat biopsies
Measured: 6 months after renal denervation
Secondary outcomes (2)
Heart rate variability
Measured: 6 months after renal denervation
Body composition
Measured by DXA
Measured: 6 months after renal denervation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startJan 2014
- Primary completion22 Oct 2018
- Study completion22 Oct 2018
Why it stopped: Renal denervation has not been used as clinical method in our hospital the last two years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonas Andersson, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057224
- Sponsor's protocol ID
- joan2014
- Status last verified
- Aug 2019
- First submitted
- 29 Jan 2014
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Cardiovascular Effects of Renal Denervation
- ClinicalTrials.gov ID
- NCT02057224
- Acronym / sponsor ID
- joan2014
- Conditions
- Insulin Resistance, Hypertension
- Keywords
- Renal denervation, Hypertension, Insulin resistance, Adipose tissue function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Renal denervation has not been used as clinical method in our hospital the last two years
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 22 Oct 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 7 Feb 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 has recently shown to improve glucose metabolism and insulin sensitivity in addition to reducing blood pressure. The mechanisms are however unclear. The investigators hypothesize that renal denervation alters adipose tissue function by reduced sympathetic outflow, measured by fat biopsies and markers of inflammation and insulin sensitivity. 15 clinical patients undergoing renal denervation are recruited to the study investigating anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies at baseline and 6 months after renal denervation.
Detailed description
Renal denervation, a catheter-based approach to reduce renal sympathetic afferent and efferent activity has been used successfully to treat drug-resistant hypertension. Previous studies has demonstrated a reduction of muscle sympathetic nerve activity and renal and total body noradrenaline spillover. In addition, renal denervation seems to improve glucose metabolism and insulin sensitivity, representing the first potential nonpharmaceutical approach for treating insulin resistance. However, the mechanisms are unclear. There is a clear relationship between sympathetic overactivity and insulin resistance. Activation of the sympathetic nervous systems contributes to insulin resistance and metabolic disorders and insulin itself induces sympathetic overactivity. One possible explanation to improved glucose metabolism after renal denervation is altered adipose tissue function (due to the reduction in sympathetic activity). Therefore,15 individuals undergoing renal denervation are recruited. The clinical study includes anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies before renal denervation and after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Procedure: Renal denervation using Medtronic Symplicity System (mono-electrode)15 clinical patients undergoing renal denervation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Essential hypertension
- Systolic blood pressure >160 mm Hg despite ≥3 antihypertensive drugs
- Clinical patients accepted for renal denervation
Key exclusion criteria (5 listed)
- Type 1 diabetes
- Pregnancy
- Glomerular filtration rate ≤45 ml/min/1,73 m2
- Pacemaker/ICD
- Myocardial infarction/stroke the last 12 months
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 denervation using Medtronic Symplicity System (mono-electrode)Secondary hypertension is excluded by an extensive preoperative clinical investigation and the renal artery anatomy is visualized by computer tomography (with contrast). By cannulating the femoral artery both renal arteries are treated by a radiofrequency-catheter, 4-6 ablations in each artery. | Procedure or surgery | Single arm |
Primary outcome
Adipose tissue function
Time frame: 6 months after renal denervation
Fat biopsies
2 secondary outcomes
Heart rate variability
Time frame: 6 months after renal denervation
Body composition
Time frame: 6 months after renal denervation
Results and safety
The study was stopped early (reason given: Renal denervation has not been used as clinical method in our hospital the last two years). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal denervation using Medtronic Symplicity System (mono-electrode) in people with Insulin Resistance and Hypertension, run by Umeå University at 1 site in Sweden.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 12 Aug 2019. 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 Sweden. 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.
Are results available for this study?
The study was stopped early (reason given: Renal denervation has not been used as clinical method in our hospital the last two years). Results are not available in the source record.
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?
Adipose tissue function (time frame: 6 months after renal denervation). 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 12 Aug 2019.