HypertensionNCT00742066
Role of AT1-receptor Blockers in Insulin-induced Vasodilation.
A study testing Irbesartan and Felodipine in people with Hypertension and Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In this study we hypothesize that blocking the angiotensin II AT1-receptor improves the insulin-induced microvascular dilatation. Objectives: 1. Does blockade of the angiotensin II AT1-receptor improve the insulin-induced microvascular effects in hypertensive patients. 2. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Insulin Resistance, Microcirculation
- What is being tested?
- Irbesartan and Felodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2008to Jul 2009
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- hypertensive subjects:
- 18-60 years
- Caucasian
- untreated hypertension >140/90mmHg.
- normotensive subjects:
- 18-60 years
- Caucasian
- Blood pressure <140/90 mmHg.
Who cannot join
- Obesity (BMI>27kg/m2)
- Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
- Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA
- Smoking
- Alcohol use >4U/day
- Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs)
- Pregnancy
- Wearing contact lenses
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Hospital Maastricht
Maastricht, P.O. Box 5800, 6202 AZ
About this study
Official title: Insulin-induced Microvascular Activity in Patients With Essential Hypertension: a Possible Role for Angiotensin II AT1-receptor Blockers.
In this study we hypothesize that blocking the angiotensin II AT1-receptor improves the insulin-induced microvascular dilatation. Objectives: 1. Does blockade of the angiotensin II AT1-receptor improve the insulin-induced microvascular effects in hypertensive patients. 2. Does blockade of the angiotensin II AT1-receptor impair the insulin-induced microvascular effects in normotensive control subjects?
- Conditions
- Hypertension, Insulin Resistance, Microcirculation
- Being tested
- Irbesartan, Felodipine, Placebo
- Keywords
- Hypertension, Insulin resistance, Microcirculation, Angiotensin II receptor blocker
- Medical subject headings
- Hypertension, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
Also called Aprovel C09CA04
Single dose 600mg orally
FelodipineDrug
Also called Plendil C08CA02
single dose 10mg Felodipine ER
PlaceboDrug
Single dose tablet orally
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Irbesartan Receives: Drug: Irbesartan |
| II | Active comparator | Felodipine Receives: Drug: Felodipine |
| III | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional recruitment of capillaries in the skin
Measured: July 2009
Secondary outcomes (4)
perfused capillary density in the nailfold
Measured: July 2009
Endothelium- (in)dependent vasodilatation of finger skin microcirculation
Measured: July 2009
Density of arterioles, capillaries and venules in the bulbar conjunctiva.
Measured: July 2009
Diameter of arterioles and venules in the bulbar conjunctiva
Measured: July 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- CDA Stehouwer, Prof., Study chair, Univeristy Hospital Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742066
- Sponsor's protocol ID
- MEC 07-2-115
- Status last verified
- Mar 2011
- First submitted
- 26 Aug 2008
- Last updated
- 17 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin-induced Microvascular Activity in Patients With Essential Hypertension: a Possible Role for Angiotensin II AT1-receptor Blockers.
- ClinicalTrials.gov ID
- NCT00742066
- Acronym / sponsor ID
- MEC 07-2-115
- Conditions
- Hypertension, Insulin Resistance, Microcirculation
- Keywords
- Hypertension, Insulin resistance, Microcirculation, Angiotensin II receptor blocker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 27 Aug 2008 (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.
In this study we hypothesize that blocking the angiotensin II AT1-receptor improves the insulin-induced microvascular dilatation. Objectives: 1. Does blockade of the angiotensin II AT1-receptor improve the insulin-induced microvascular effects in hypertensive patients. 2. Does blockade of the angiotensin II AT1-receptor impair the insulin-induced microvascular effects in normotensive control subjects?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: IrbesartanIrbesartan |
| II | Active comparator | Drug: FelodipineFelodipine |
| III | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18-60 years
- Caucasian
- untreated hypertension >140/90mmHg.
- 18-60 years
- Caucasian
Key exclusion criteria (8 listed)
- Obesity (BMI>27kg/m2)
- Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
- Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA
- Smoking
- Alcohol use >4U/day
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 |
|---|---|---|
| IrbesartanAlso: Aprovel C09CA04Single dose 600mg orally | Drug | I |
| FelodipineAlso: Plendil C08CA02single dose 10mg Felodipine ER | Drug | II |
| PlaceboSingle dose tablet orally | Drug | III |
Primary outcome
functional recruitment of capillaries in the skin
Time frame: July 2009
4 secondary outcomes
perfused capillary density in the nailfold
Time frame: July 2009
Endothelium- (in)dependent vasodilatation of finger skin microcirculation
Time frame: July 2009
Density of arterioles, capillaries and venules in the bulbar conjunctiva.
Time frame: July 2009
Diameter of arterioles and venules in the bulbar conjunctiva
Time frame: July 2009
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2011.
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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.
CDA Stehouwer, Prof. study chair
Univeristy Hospital Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irbesartan and Felodipine in people with Hypertension and Insulin Resistance, run by Maastricht University Medical Center 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Mar 2011. 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. Some participants in this study may receive a placebo. 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?
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?
functional recruitment of capillaries in the skin (time frame: July 2009). 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 17 Mar 2011.