FlushingNCT00930839
Role of Prostaglandins on Niacin-Induced Flushing
An observational study of Flushing, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
This study will focus on investigating the nicotinic acid stimulated release of prostaglandin D2 in normal controls. In subsequent studies, the investigators would like to further explore this pathway in people with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Flushing
- What is being tested?
- Niacin and aspirin
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Feb 2010
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal, healthy control subjects, males and females, ages 30-80
Who may be able to join
- Healthy controls ages 30-80
Who cannot join
- Presence of type 1 diabetes or type 2 diabetes
- Presence of clinically significant neuropathy, (Dyck stage >2b) defined by abnormal neurologic testing (neurologic physical exam, nerve conduction, autonomic and quantitative sensory tests)
- History of major macrovascular events such as myocardial infarction or stroke within the past 3 months
- Participation in another clinical trial concurrently or within 30 days prior to entry into this study.
- Uncontrolled or untreated hypothyroidism as evidenced by TSH concentrations >4.8 uU/ml
- Other serious medical conditions which, in the opinion of the investigator, would compromise the subject's participation in the study, including sensitivity to aspirin
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- Abnormalities of liver function defined as any liver enzymes (AST, ALT, SGPT, SGOT) greater than 3 times the upper limit of normal
- History of NYHA Class IV congestive heart failure.
- Allergy to Niaspan or aspirin
- Use of drugs known to affect prostaglandin metabolism such as angiotensin converting enzyme inhibitors (ACE) inhibitors and angiotensin receptor blockers (ARBs) will be allowed with stable use for 3 months.
- Pregnancy or breastfeeding
- History of peptic ulcer disease
- Current history of smoking
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Virgnia Medical School, Strelitz Diabetes Center
Norfolk, Virginia, 23510f
About this study
Official title: Exploring the Role of Prostaglandin D2 and the DP1 Receptor on Nicotinic Acid Induced Flushing
This study will focus on investigating the nicotinic acid stimulated release of prostaglandin D2 in normal controls. In subsequent studies, the investigators would like to further explore this pathway in people with type 2 diabetes. Enhanced blood flow (or flushing) may be compromised or exaggerated in type 2 diabetes particularly in those with impairment of autonomic function measured as the respiratory heart rate variability (HRV) of different frequencies reflecting the balance between the sympathetic and parasympathetic nervous systems. The investigators hypothesize that the vasodilatory effects induced by nicotinic acid will be different in glabrous and hairy skin and that autonomic imbalance may alter the response.
Read the detailed description
The investigators propose that nicotinic acid (NA) stimulates release of prostaglandin D2 (PGD2). To fully understand this mechanism, the investigators will examine the systemic release of PGD2 and skin blood flow using laser Doppler (LDF) on the upper and lower limbs of healthy control subjects. The investigators will quantify and establish the effects of oral nicotinic acid (Niaspan®) given alone and in combination with aspirin on:
- skin blood flow using laser Doppler (LDF) of glabrous and hairy skin of the forearm of healthy subjects
- the severity and intensity of flushing using a visual analog scale, FAST tool, and whether aspirin is able to block the flushing response
- the impact on sympathetic/parasympathetic balance using the various frequencies of heart rate variability (HRV) which reflect the contribution of the different divisions of the autonomic nervous system (ANS)
- circulating levels of PGD2 and other neuropeptides to determine other mediators of the flushing response. This will allow us to conclude whether this pathway is intact and explore other non-DP1 vasodilatory mechanisms.
- Langerhans cell density in epidermis and microvasculature using immunohistochemistry of Langerin (measured as CD1a) in 3 mm skin biopsies of volar and hairy surfaces of the forearm and hairy surface of the lateral aspect of proximal lower limb. To date, there is very little known about the density or distribution of Langerhans cells. The PGD2 receptor DP1 will be examined for its content in the epidermis using immunohistochemistry or RTPCR.
- Conditions
- Flushing
- Being tested
- Niacin and aspirin
- Keywords
- Niacin, Prostaglandin D2, Flushing, Nicotinic acid stimulated release of prostaglandin D2
- Medical subject headings
- Flushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacin and aspirinDrug
Also called Niaspan, Nicotinic acid
1000 mg Niacin, 325 mg aspirin
| Study group | Role | What they receive |
|---|---|---|
| Controls | Normal, healthy controls, males and females, ages 30-80 Receives: Drug: Niacin and aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy measures are skin perfusion measurements and neurological measures.
Measured: 30 minutes after administration of Niacin
Secondary outcomes (1)
Secondary measures include blood chemistries
Measured: 15-30 min serial measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlushingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Investigators
- Aaron I Vinik, MD, PhD, Principal investigator, Eastern Virginia Medical School, Strelitz Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930839
- Sponsor's protocol ID
- A10-597
- Status last verified
- Mar 2010
- First submitted
- 30 Jun 2009
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Prostaglandin D2 and the DP1 Receptor on Nicotinic Acid Induced Flushing
- ClinicalTrials.gov ID
- NCT00930839
- Acronym / sponsor ID
- A10-597
- Conditions
- Flushing
- Keywords
- Niacin, Prostaglandin D2, Flushing, Nicotinic acid stimulated release of prostaglandin D2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 2 Jul 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.
This study will focus on investigating the nicotinic acid stimulated release of prostaglandin D2 in normal controls. In subsequent studies, the investigators would like to further explore this pathway in people with type 2 diabetes. Enhanced blood flow (or flushing) may be compromised or exaggerated in type 2 diabetes particularly in those with impairment of autonomic function measured as the respiratory heart rate variability (HRV) of different frequencies reflecting the balance between the sympathetic and parasympathetic nervous systems. The investigators hypothesize that the vasodilatory effects induced by nicotinic acid will be different in glabrous and hairy skin and that autonomic imbalance may alter the response.
Detailed description
The investigators propose that nicotinic acid (NA) stimulates release of prostaglandin D2 (PGD2). To fully understand this mechanism, the investigators will examine the systemic release of PGD2 and skin blood flow using laser Doppler (LDF) on the upper and lower limbs of healthy control subjects. The investigators will quantify and establish the effects of oral nicotinic acid (Niaspan®) given alone and in combination with aspirin on:
- skin blood flow using laser Doppler (LDF) of glabrous and hairy skin of the forearm of healthy subjects
- the severity and intensity of flushing using a visual analog scale, FAST tool, and whether aspirin is able to block the flushing response
- the impact on sympathetic/parasympathetic balance using the various frequencies of heart rate variability (HRV) which reflect the contribution of the different divisions of the autonomic nervous system (ANS)
- circulating levels of PGD2 and other neuropeptides to determine other mediators of the flushing response. This will allow us to conclude whether this pathway is intact and explore other non-DP1 vasodilatory mechanisms.
- Langerhans cell density in epidermis and microvasculature using immunohistochemistry of Langerin (measured as CD1a) in 3 mm skin biopsies of volar and hairy surfaces of the forearm and hairy surface of the lateral aspect of proximal lower limb. To date, there is very little known about the density or distribution of Langerhans cells. The PGD2 receptor DP1 will be examined for its content in the epidermis using immunohistochemistry or RTPCR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Drug: Niacin and aspirinNormal, healthy controls, males and females, ages 30-80 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal, healthy control subjects, males and females, ages 30-80
Key inclusion criteria (1 listed)
- Healthy controls ages 30-80
Key exclusion criteria (14 listed)
- Presence of type 1 diabetes or type 2 diabetes
- Presence of clinically significant neuropathy, (Dyck stage >2b) defined by abnormal neurologic testing (neurologic physical exam, nerve conduction, autonomic and quantitative sensory tests)
- History of major macrovascular events such as myocardial infarction or stroke within the past 3 months
- Participation in another clinical trial concurrently or within 30 days prior to entry into this study.
- Uncontrolled or untreated hypothyroidism as evidenced by TSH concentrations >4.8 uU/ml
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 |
|---|---|---|
| Niacin and aspirinAlso: Niaspan, Nicotinic acid1000 mg Niacin, 325 mg aspirin | Drug | Controls |
Primary outcome
The primary efficacy measures are skin perfusion measurements and neurological measures.
Time frame: 30 minutes after administration of Niacin
1 secondary outcome
Secondary measures include blood chemistries
Time frame: 15-30 min serial measurements
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 10 Mar 2010.
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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.
Aaron I Vinik, MD, PhD principal investigator
Eastern Virginia Medical School, Strelitz Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Flushing, run by Eastern Virginia Medical School at 1 site in United States.
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 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 10 Mar 2010. 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 United States. 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?
The primary efficacy measures are skin perfusion measurements and neurological measures. (time frame: 30 minutes after administration of Niacin). 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 10 Mar 2010.