HypertensionNCT00742456
Microvascular Dilatation After Endogenous Induced Hyperinsulinemia
A study testing Glucose solution in people with Hypertension and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In this study we will examine if the insulin-induced microvascular effects will occur after a physiological stimulus (i.e. a oral glucose tolerance test). With that the physiological importance of the insulin-induced microvascular dilatation can be elucidated. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Obesity
- What is being tested?
- Glucose solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Aug 2010
- 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
- healthy normotensive subjects:
- 18-60 years
- Caucasian
- Blood pressure <140/90 mmHg
- obese normotensive subjects:
- 18-60 years
Show all 30Show fewer
- Caucasian
- Blood pressure <140/90 mmHg
- BMI 30-38kg/m2
- hypertensive subjects:
- 18-60 years
- Caucasian
- Untreated hypertension >140/90mmHg.
- Exclusion Criteria for healthy normotensive and hypertensive subjects:
- Obesity (BMI>27kg/m2)
- Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
- 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
- for normotensive obese subjects:
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insulin-induced Microvascular Dilatation During a Physiological Stimulus - Studies in Hypertension and Obesity.
In this study we will examine if the insulin-induced microvascular effects will occur after a physiological stimulus (i.e. a oral glucose tolerance test). With that the physiological importance of the insulin-induced microvascular dilatation can be elucidated. In this study we hypothesize that oral glucose intake and consequently the endogenous induced hyperinsulinemia will lead to insulin-induced microvascular dilatation in healthy normotensive subjects. Furthermore, we suggest that the insulin-mediated microvascular dilatation, resulting from this physiological induced hyperinsulinemia, will be less in hypertensive and obese subjects compared to healthy controls.
- Conditions
- Hypertension, Obesity
- Being tested
- Glucose solution, Placebo
- Keywords
- Microcirculation, Insulin, Hypertension, Obesity
- Medical subject headings
- Hypertension, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose solutionDietary supplement
single oral intake of 250 ml glucose solution (75gr sugar in 250ml of water)
PlaceboDietary supplement
single intake of placebo solution (250ml of sweet flavored water, no sugar added), orally
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Glucose Receives: Dietary Supplement: Glucose solution |
| II | Placebo comparator | Placebo Receives: Dietary Supplement: 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: January 2009 - January 2010
Secondary outcomes (5)
Perfused capillary density in the nailfold.
Measured: January 2009 - January 2010
Endothelium- (in)dependent vasodilatation of finger skin microcirculation
Measured: January 2009 - January 2010
Density of arterioles, capillaries and venules in the bulbar conjunctiva.
Measured: January 2009 - January 2010
Diameter of arterioles and venules in the bulbar conjunctiva.
Measured: January 2009 - January 2010
Insulin sensitivity (HOMA-IR)
Measured: January 2009 - January 2010
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 startJan 2009
- Primary completionAug 2010
- Study completionAug 2010
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 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
- NCT00742456
- Sponsor's protocol ID
- 08-2-031 MEC
- Status last verified
- Feb 2011
- First submitted
- 26 Aug 2008
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin-induced Microvascular Dilatation During a Physiological Stimulus - Studies in Hypertension and Obesity.
- ClinicalTrials.gov ID
- NCT00742456
- Acronym / sponsor ID
- 08-2-031 MEC
- Conditions
- Hypertension, Obesity
- Keywords
- Microcirculation, Insulin, Hypertension, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- 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 will examine if the insulin-induced microvascular effects will occur after a physiological stimulus (i.e. a oral glucose tolerance test). With that the physiological importance of the insulin-induced microvascular dilatation can be elucidated. In this study we hypothesize that oral glucose intake and consequently the endogenous induced hyperinsulinemia will lead to insulin-induced microvascular dilatation in healthy normotensive subjects. Furthermore, we suggest that the insulin-mediated microvascular dilatation, resulting from this physiological induced hyperinsulinemia, will be less in hypertensive and obese subjects compared to healthy controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Dietary Supplement: Glucose solutionGlucose |
| II | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (30 listed)
- 18-60 years
- Caucasian
- Blood pressure <140/90 mmHg
- 18-60 years
- Caucasian
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Glucose solutionsingle oral intake of 250 ml glucose solution (75gr sugar in 250ml of water) | Dietary supplement | I |
| Placebosingle intake of placebo solution (250ml of sweet flavored water, no sugar added), orally | Dietary supplement | II |
Primary outcome
Functional recruitment of capillaries in the skin.
Time frame: January 2009 - January 2010
5 secondary outcomes
Perfused capillary density in the nailfold.
Time frame: January 2009 - January 2010
Endothelium- (in)dependent vasodilatation of finger skin microcirculation
Time frame: January 2009 - January 2010
Density of arterioles, capillaries and venules in the bulbar conjunctiva.
Time frame: January 2009 - January 2010
Diameter of arterioles and venules in the bulbar conjunctiva.
Time frame: January 2009 - January 2010
Insulin sensitivity (HOMA-IR)
Time frame: January 2009 - January 2010
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 23 Feb 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 Glucose solution in people with Hypertension and Obesity, 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 30 inclusion and 0 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 23 Feb 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?
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 - January 2010). 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 23 Feb 2011.