Metabolic SyndromeNCT01911078
Renal Sympathetic Denervation in Metabolic Syndrome (Metabolic Syndrome Study)
A study testing Renal Denervation and EnligHTN™ Renal Denervation System. in people with Metabolic Syndrome, run by Abbott Medical Devices at 1 site in Greece.
Trial summary
The purpose of this clinical investigation is to determine the effects of renal sympathetic denervation on insulin resistance and muscle sympathetic nerve activity in patients with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Renal Denervation and EnligHTN™ Renal Denervation System.
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2014to Jun 2016
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with office blood pressure ≥140/90 mmHg and 24-hour ambulatory blood pressure ≥130/80 mmHg at Baseline despite the stable use of at least two anti-hypertensive drugs at maximum tolerated doses of the patient for at least 4 weeks
- Patient with a fasting glucose ≥100 mg/dL (≥5.6 mmol/L) at Baseline or on drug treatment for elevated glucose
- Patient with a waist circumference ≥102 cm (≥40 inches) for male or ≥88 cm (≥35 inches) for female at Baseline
- Patient with any of the remaining two metabolic syndrome diagnostic criteria listed as follows at Baseline
- Triglycerides ≥150 mg/dL (≥1.7 mmol/L) or on drug treatment for elevated triglycerides
- High density lipid cholesterol (HDL-C) <40 mg/dL (<1.03 mmol/L) for male or <50 mg/dL (<1.30 mmol/L) for female or on drug treatment for reduced HDL-C
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- Patient is ≥18 and ≤70 years old
- Patient must be able and willing to provide written informed consent to participate in this clinical investigation
- Patient must be able and willing to comply with the required follow-up schedule
Who cannot join
- Patient with secondary hypertension
- Patient with type I diabetes mellitus or type II diabetes mellitus requiring insulin therapy
- Patient with prior renal angioplasty, renal denervation, indwelling renal stents and/or aortic stent grafts
- Patient with renal arteries <4.0 mm in diameter
- Patient with significant renovascular abnormalities (such as renal artery stenosis >30%)
- Patient with an estimated glomerular filtration rate (eGFR) of <45 mL/min per 1.73 m2 using the Modified Diet in Renal Disease (MDRD) formula
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- Patient with hemodynamically significant valvular heart disease, as determined by Study Investigator
- Patient has had a myocardial infarction, unstable angina pectoris or cerebrovascular accident less than 180 days at Baseline or is expected to have cardiovascular intervention within the next 180 days
- Patient is in chronic atrial fibrillation/flutter or with severe conduction abnormalities or with an implantable cardioverter defibrillator (ICD) or pacemaker whose settings cannot allow for radiofrequency (RF) energy delivery
- Patient is currently being treated with drugs that cause salt retention (such as systemic corticosteroids or fludrocortisone), centrally acting sympatholytic antihypertensive drugs, direct vasodilators (such as alpha blockers) and continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea
- Patient with an active systemic infection or blood-clotting abnormalities or allergy to radiographic contrast
- Patient is pregnant or of childbearing potential and is not using adequate contraceptive methods or nursing
- Patient is participating in another clinical investigation
- Patient has a life expectancy less than 12 months, as determined by Study Investigator
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical investigation is to determine the effects of renal sympathetic denervation on insulin resistance and muscle sympathetic nerve activity in patients with metabolic syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- Renal Denervation, EnligHTN™ Renal Denervation System.
- Keywords
- Metabolic syndrome, Renal denervation, Renal artery, Muscle sympathetic nerve activity
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal DenervationProcedure or surgery
Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN™ Renal Denervation System.Device
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation Group | Other | Subjects receiving renal denervation procedure. Receives: Procedure: Renal Denervation; Device: EnligHTN™ Renal Denervation System. |
| Control Group | No intervention | Subjects not receiving renal denervation procedure. Subjects are randomized in a 3:1 ratio to either Renal Denervation Group or Control Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin resistance from baseline to 3 months after renal denervation
To determine the effects of renal sympathetic denervation on insulin resistance (determined by the Homeostasis Model Assessment - Insulin Resistance method) at 3 months after renal denervation
Measured: Baseline and Month 3
Change in muscle sympathetic nerve activity (MSNA) from baseline to 3 months after renal denervation
To determine the effects of renal sympathetic denervation on MSNA at 3 months after renal denervation
Measured: Baseline and Month 3
Secondary outcomes (2)
Change in insulin resistance from baseline to 12 months after renal denervation
To determine the effects of renal sympathetic denervation on insulin resistance long-term (12 months after renal denervation).
Measured: Baseline and Month 12
Change in muscle sympathetic nerve activity (MSNA) from baseline to 12 months after renal denervation
To determine the effects of renal sympathetic denervation on MSNA long-term (12 months after renal denervation).
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911078
- Sponsor's protocol ID
- CI-12-079-EU-RD
- Status last verified
- Jan 2019
- First submitted
- 24 Jul 2013
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Sympathetic Denervation in Metabolic Syndrome (Metabolic Syndrome Study)
- ClinicalTrials.gov ID
- NCT01911078
- Acronym / sponsor ID
- CI-12-079-EU-RD
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic syndrome, Renal denervation, Renal artery, Muscle sympathetic nerve activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jul 2013 (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.
The purpose of this clinical investigation is to determine the effects of renal sympathetic denervation on insulin resistance and muscle sympathetic nerve activity in patients with metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation Group | Other | Procedure: Renal Denervation, Device: EnligHTN™ Renal Denervation System.Subjects receiving renal denervation procedure. |
| Control Group | No intervention | –Subjects not receiving renal denervation procedure. Subjects are randomized in a 3:1 ratio to either Renal Denervation Group or Control Group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient with office blood pressure ≥140/90 mmHg and 24-hour ambulatory blood pressure ≥130/80 mmHg at Baseline despite the stable use of at least two anti-hypertensive drugs at maximum tolerated doses of the patient for at least 4 weeks
- Patient with a fasting glucose ≥100 mg/dL (≥5.6 mmol/L) at Baseline or on drug treatment for elevated glucose
- Patient with a waist circumference ≥102 cm (≥40 inches) for male or ≥88 cm (≥35 inches) for female at Baseline
- Patient with any of the remaining two metabolic syndrome diagnostic criteria listed as follows at Baseline
- Patient is ≥18 and ≤70 years old
Key exclusion criteria (14 listed)
- Patient with secondary hypertension
- Patient with type I diabetes mellitus or type II diabetes mellitus requiring insulin therapy
- Patient with prior renal angioplasty, renal denervation, indwelling renal stents and/or aortic stent grafts
- Patient with renal arteries <4.0 mm in diameter
- Patient with significant renovascular abnormalities (such as renal artery stenosis >30%)
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 artery ablation with the EnligHTN™ Renal Denervation System. | Procedure or surgery | Renal Denervation Group |
| EnligHTN™ Renal Denervation System. | Device | Renal Denervation Group |
Primary outcome
Change in insulin resistance from baseline to 3 months after renal denervation
Time frame: Baseline and Month 3
To determine the effects of renal sympathetic denervation on insulin resistance (determined by the Homeostasis Model Assessment - Insulin Resistance method) at 3 months after renal denervation
Change in muscle sympathetic nerve activity (MSNA) from baseline to 3 months after renal denervation
Time frame: Baseline and Month 3
To determine the effects of renal sympathetic denervation on MSNA at 3 months after renal denervation
2 secondary outcomes
Change in insulin resistance from baseline to 12 months after renal denervation
Time frame: Baseline and Month 12
Change in muscle sympathetic nerve activity (MSNA) from baseline to 12 months after renal denervation
Time frame: Baseline and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 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 and EnligHTN™ Renal Denervation System. in people with Metabolic Syndrome, run by Abbott Medical Devices at 1 site in Greece.
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 9 inclusion and 14 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: finished, as of the sponsor's last update on 4 Feb 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 Greece. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in insulin resistance from baseline to 3 months after renal denervation (time frame: Baseline and Month 3). 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 4 Feb 2019.