- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00930839
Role of Prostaglandins on Niacin-Induced Flushing
Exploring the Role of Prostaglandin D2 and the DP1 Receptor on Nicotinic Acid Induced Flushing
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Virginia
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Norfolk, Virginia, United States, 23510f
- Eastern Virgnia Medical School, Strelitz Diabetes Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Healthy controls ages 30-80
Exclusion Criteria:
- 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
- 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
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Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Controls
Normal, healthy controls, males and females, ages 30-80
|
1000 mg Niacin, 325 mg aspirin
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary efficacy measures are skin perfusion measurements and neurological measures.
Time Frame: 30 minutes after administration of Niacin
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30 minutes after administration of Niacin
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary measures include blood chemistries
Time Frame: 15-30 min serial measurements
|
15-30 min serial measurements
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aaron I Vinik, MD, PhD, Eastern Virginia Medical School, Strelitz Diabetes Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Manifestations
- Flushing
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Antimetabolites
- Micronutrients
- Hypolipidemic Agents
- Lipid Regulating Agents
- Vitamins
- Vitamin B Complex
- Aspirin
- Nicotinic Acids
- Niacin
Other Study ID Numbers
- A10-597
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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