Insulin ResistancePhase 3DREAMSNCT01465724
Denervation of the REnal Artery in Metabolic Syndrome
A Phase 3 study testing Renal denervation in people with Insulin Resistance and Blood Pressure, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The current prevalence of hypertension as part of the metabolic syndrome is substantial and is increasing with the rise of obesity worldwide. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a common and key factor in disease states as obesity-related hypertension (ORH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin Resistance, Blood Pressure
- 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
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2011to Sep 2014
- Phase
- Phase 3
- 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
- Patients should have a high fasting glucose (fasting serum glucose ≥5.6 mmol/L (≥100 mg/dL)), without the use of antidiabetic drugs at the time of inclusion AND should have a 24 hour ambulatory SBP >130 mmHg, without the use of antihypertensive drugs at the time of inclusion.
- Patients should fulfil one or more other criteria to meet the definition of the metabolic syndrome.
- Individual understands the study procedures, alternative treatments available, risks involved with the study and voluntarily agrees to participate by giving informed consent.
- Individual is over 18 years of age on the day of signing informed consent.
Who cannot join
- SBP >180 mmHg and/or DBP >110 mmHg during one or more screening measurements.
- 24-hour ambulatory SBP >170 mmHg and/or 24-hour ambulatory DBP >100 mmHg at time of inclusion.
- Individual is treated with more than one type of antihypertensive medication at time of inclusion.
- Individual is treated with more than one type of drug for diabetes mellitus 2 at time of inclusion and/or the medication for DM type 2 can not be stopped.
- Individual has a treatable secondary cause of hypertension.
- Individual has renal artery anatomy that is ineligible for treatment.
Show all 19Show fewer
- Individual has an estimated glomerular filtration rate (eGFR) of <45mL/min/1.73m2, using the MDRD calculation.
- Individual has type 1 diabetes mellitus.
- Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- Individual has scheduled or planned surgery or cardiovascular intervention in the next 6 months.
- Individual has hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous.
- Individual has an implantable cardioverter defibrillator (ICD) or pacemaker whose settings cannot allow for RF energy delivery.
- Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, or significant anaemia).
- Individual is pregnant, nursing or planning to be pregnant.
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- Individual is currently enrolled in another investigational drug or device trial.
- Individual is currently being treated with any of the following medications:
- Drugs that cause salt retention (e.g., systemic corticosteroids and fludrocortisone)
- Acenocoumarol or phenprocoumon that cannot be temporarily stopped for the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sympathetic Denervation of the Renal Artery for the Treatment of Obesity-related Hypertension and Insulin Resistance
The current prevalence of hypertension as part of the metabolic syndrome is substantial and is increasing with the rise of obesity worldwide. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a common and key factor in disease states as obesity-related hypertension (ORH). The renal sympathetic nerves are a major contributor to the complex pathophysiology of this elevated SNS activity. Percutaneous renal denervation (PRDN), the deliberate disruption of the nerves connecting the kidneys with the central nervous system, has been shown to be an effective means of modulating elevated SNS activity.
This current study is an observational feasibility study, with the aim to investigate the effect of renal denervation on changes in insulin resistance and blood pressure in patients with obesity related hypertension. The investigators will study different variables: a laboratorial set, a set of blood pressure measurements and a set of investigations in the vascular laboratory.
Read more
Hypothesis
- The investigators hypothesize that renal denervation has a beneficial effect on insulin resistance.
- The investigators hypothesize that there will be no complications related to the device or procedure.
Read the detailed description
Objectives: The objectives of this study are: to compare changes in insulin resistance in patients with ORH after RDN; to evaluate the safety of PRDN in this patient group; to compare changes in blood pressure, laboratory parameters, arterial stiffness and SNS-activity after PRDN.
Study design: Prospective observational feasibility-study.
Study population: Patients with a high fasting glucose (fasting serum glucose ≥5.6 mmol/L(100 mg/dL)) and with an ambulatory systolic blood pressure >130mmHg.
Major endpoints: The effect of RDN on: insulin resistance, blood pressure and major adverse events.
- Conditions
- Insulin Resistance, Blood Pressure
- Being tested
- Renal denervation
- Keywords
- Insulin resistance, Insulin sensitivity, HOMA-IR, blood pressure, Renal denervation, renal sympathetic denervation, renal ablation
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervationProcedure or surgery
Also called Symplicity Catheter system
percutaneous selective renal sympathetic denervation with the use of the Symplicity Catheter system.
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation | Experimental | Not described Receives: Procedure: Renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Insulin resistance before and 12 months after renal denervation
To investigate the influence of percutaneous renal sympathetic denervation on insulin resistance. Hereby evaluating an Oral Glucose Tolerance Test before and after renal denervation
Measured: T=0, T=6 months, and t=12 months
Secondary outcomes (4)
Difference in blood pressure before and after renal denervation
Measured: t=0, t=6 months, and t=12 months
Safety
Major adverse events, characterized by myocardial infarction, cerebrovascular accident or all-cause mortality.
Measured: one year
Fasting glucose before and after renal denervation
Measured: t=0 and t=12 months
Change in Muscle sympathetic nerve activity (MSNA)after renal denervation
Measured: t=0 and t=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 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2014
- Study completionSep 2014
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 UMC UtrechtThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michiel Voskuil, MD, PhD, UMC Utrecht
- Investigators
- Michiel Voskuil, MD, PhD, Principal investigator, UMC UtrechtWillemien Verloop, MD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465724
- Sponsor's protocol ID
- 11-265
- Acronym
- DREAMS
- Status last verified
- Dec 2014
- First submitted
- 25 Oct 2011
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic Denervation of the Renal Artery for the Treatment of Obesity-related Hypertension and Insulin Resistance
- ClinicalTrials.gov ID
- NCT01465724
- Acronym / sponsor ID
- DREAMS / 11-265
- Conditions
- Insulin Resistance, Blood Pressure
- Keywords
- Insulin resistance, Insulin sensitivity, HOMA-IR, blood pressure, Renal denervation, renal sympathetic denervation, renal ablation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Nov 2011 (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 current prevalence of hypertension as part of the metabolic syndrome is substantial and is increasing with the rise of obesity worldwide. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a common and key factor in disease states as obesity-related hypertension (ORH). The renal sympathetic nerves are a major contributor to the complex pathophysiology of this elevated SNS activity. Percutaneous renal denervation (PRDN), the deliberate disruption of the nerves connecting the kidneys with the central nervous system, has been shown to be an effective means of modulating elevated SNS activity.
This current study is an observational feasibility study, with the aim to investigate the effect of renal denervation on changes in insulin resistance and blood pressure in patients with obesity related hypertension. The investigators will study different variables: a laboratorial set, a set of blood pressure measurements and a set of investigations in the vascular laboratory.
Hypothesis
- The investigators hypothesize that renal denervation has a beneficial effect on insulin resistance.
- The investigators hypothesize that there will be no complications related to the device or procedure.
Detailed description
Objectives: The objectives of this study are: to compare changes in insulin resistance in patients with ORH after RDN; to evaluate the safety of PRDN in this patient group; to compare changes in blood pressure, laboratory parameters, arterial stiffness and SNS-activity after PRDN.
Study design: Prospective observational feasibility-study.
Study population: Patients with a high fasting glucose (fasting serum glucose ≥5.6 mmol/L(100 mg/dL)) and with an ambulatory systolic blood pressure >130mmHg.
Major endpoints: The effect of RDN on: insulin resistance, blood pressure and major adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | Experimental | Procedure: Renal denervation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients should have a high fasting glucose (fasting serum glucose ≥5.6 mmol/L (≥100 mg/dL)), without the use of antidiabetic drugs at the time of inclusion AND should have a 24 hour ambulatory SBP >130 mmHg, without the use of antihypertensive drugs at the time of inclusion.
- Patients should fulfil one or more other criteria to meet the definition of the metabolic syndrome.
- Individual understands the study procedures, alternative treatments available, risks involved with the study and voluntarily agrees to participate by giving informed consent.
- Individual is over 18 years of age on the day of signing informed consent.
Key exclusion criteria (19 listed)
- SBP >180 mmHg and/or DBP >110 mmHg during one or more screening measurements.
- 24-hour ambulatory SBP >170 mmHg and/or 24-hour ambulatory DBP >100 mmHg at time of inclusion.
- Individual is treated with more than one type of antihypertensive medication at time of inclusion.
- Individual is treated with more than one type of drug for diabetes mellitus 2 at time of inclusion and/or the medication for DM type 2 can not be stopped.
- Individual has a treatable secondary cause of hypertension.
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 denervationAlso: Symplicity Catheter systempercutaneous selective renal sympathetic denervation with the use of the Symplicity Catheter system. | Procedure or surgery | Renal denervation |
Primary outcome
Difference in Insulin resistance before and 12 months after renal denervation
Time frame: T=0, T=6 months, and t=12 months
To investigate the influence of percutaneous renal sympathetic denervation on insulin resistance. Hereby evaluating an Oral Glucose Tolerance Test before and after renal denervation
4 secondary outcomes
Difference in blood pressure before and after renal denervation
Time frame: t=0, t=6 months, and t=12 months
Safety
Time frame: one year
Fasting glucose before and after renal denervation
Time frame: t=0 and t=12 months
Change in Muscle sympathetic nerve activity (MSNA)after renal denervation
Time frame: t=0 and t=6 months
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 30 Dec 2014.
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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.
Michiel Voskuil, MD, PhD principal investigator
UMC Utrecht
Willemien Verloop, MD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Renal denervation in people with Insulin Resistance and Blood Pressure, run by UMC Utrecht at 1 site in Netherlands.
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 4 inclusion and 19 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 30 Dec 2014. 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Difference in Insulin resistance before and 12 months after renal denervation (time frame: T=0, T=6 months, and t=12 months). 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 30 Dec 2014.