Insulin SensitivityNCT01024543
Role of Angiotensin II in Insulin-induced Microvascular Activity
A study testing Angiotensin II and Phenylephrine in people with Insulin Sensitivity and Microcirculation, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In this study we hypothesize infusion of Angiotensin II improves the insulin-induced microvascular dilatation and therefore insulin-mediated glucose uptake. Objectives: Does infusion of Angiotensin II increase insulin-mediated glucose uptake via enhanced insulin-mediated microvascular function in healthy subjects? Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Microcirculation
- What is being tested?
- Angiotensin II and Phenylephrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2006to Nov 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
- 1.18-60 years 2.Caucasian 3.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
Maastricht University Medical Centre
Maastricht, P.o. Box 5800, Netherlands, 6202 AZ
About this study
In this study we hypothesize infusion of Angiotensin II improves the insulin-induced microvascular dilatation and therefore insulin-mediated glucose uptake. Objectives: Does infusion of Angiotensin II increase insulin-mediated glucose uptake via enhanced insulin-mediated microvascular function in healthy subjects?
- Conditions
- Insulin Sensitivity, Microcirculation
- Being tested
- Angiotensin II, Phenylephrine, Placebo
- Keywords
- Angiotensin II
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin IIDrug
Angiotensin II
PhenylephrineDrug
Phenylephrine
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Sham comparator | Placebo Receives: Drug: Placebo |
| Angiotensin II | Experimental | Angiotensin II Receives: Drug: Angiotensin II |
| Phenylephrine | Active comparator | Phenylephrine Receives: Drug: Phenylephrine |
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: January 2009
Secondary outcomes (3)
perfused capillary density in the nailfold
Measured: January 2009
Endothelium- (in)dependent vasodilatation of finger skin microcirculation
Measured: January 2006
Insulin sensitivity
Measured: January 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startOct 2006
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- CDA Stehouwer, Prof, Study chair, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024543
- Sponsor's protocol ID
- MEC 06-2-074
- Status last verified
- Dec 2009
- First submitted
- 30 Nov 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Angiotensin II in Insulin-induced Microvascular Activity
- ClinicalTrials.gov ID
- NCT01024543
- Acronym / sponsor ID
- MEC 06-2-074
- Conditions
- Insulin Sensitivity, Microcirculation
- Keywords
- Angiotensin II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009
- First posted
- 2 Dec 2009 (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 infusion of Angiotensin II improves the insulin-induced microvascular dilatation and therefore insulin-mediated glucose uptake. Objectives: Does infusion of Angiotensin II increase insulin-mediated glucose uptake via enhanced insulin-mediated microvascular function in healthy subjects?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Sham comparator | Drug: PlaceboPlacebo |
| Angiotensin II | Experimental | Drug: Angiotensin IIAngiotensin II |
| Phenylephrine | Active comparator | Drug: PhenylephrinePhenylephrine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1.18-60 years 2.Caucasian 3.Blood pressure <140/90 mmHg.
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 |
|---|---|---|
| Angiotensin IIAngiotensin II | Drug | Angiotensin II |
| PhenylephrinePhenylephrine | Drug | Phenylephrine |
| Placebo | Drug | Placebo |
Primary outcome
functional recruitment of capillaries in the skin
Time frame: January 2009
3 secondary outcomes
perfused capillary density in the nailfold
Time frame: January 2009
Endothelium- (in)dependent vasodilatation of finger skin microcirculation
Time frame: January 2006
Insulin sensitivity
Time frame: January 2009
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 2 Dec 2009.
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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
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiotensin II and Phenylephrine in people with Insulin Sensitivity and Microcirculation, 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 1 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: finished, as of the sponsor's last update on 2 Dec 2009. 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?
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?
functional recruitment of capillaries in the skin (time frame: January 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 2 Dec 2009.