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Role of Prostaglandins on Niacin-Induced Flushing

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ClinicalTrials.gov Identifier: NCT00930839
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : March 10, 2010
Sponsor:
Collaborator:
Abbott
Information provided by:
Eastern Virginia Medical School

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Flushing Drug: Niacin and aspirin

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:

  1. skin blood flow using laser Doppler (LDF) of glabrous and hairy skin of the forearm of healthy subjects
  2. the severity and intensity of flushing using a visual analog scale, FAST tool, and whether aspirin is able to block the flushing response
  3. 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)
  4. 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.
  5. 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
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploring the Role of Prostaglandin D2 and the DP1 Receptor on Nicotinic Acid Induced Flushing
Study Start Date : March 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Controls
Normal, healthy controls, males and females, ages 30-80
 Drug: Niacin and aspirin
1000 mg Niacin, 325 mg aspirin
Other Names:
  • Niaspan
  • Nicotinic acid


Outcome Measures
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Primary Outcome Measures :
  1. The primary efficacy measures are skin perfusion measurements and neurological measures. [ Time Frame: 30 minutes after administration of Niacin ]

Secondary Outcome Measures :
  1. Secondary measures include blood chemistries [ Time Frame: 15-30 min serial measurements ]

Biospecimen Retention:   Samples Without DNA
Skin biopsies and serum

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal, healthy control subjects, males and females, ages 30-80
Criteria

Inclusion Criteria:

Healthy controls ages 30-80

Exclusion Criteria:

  1. Presence of type 1 diabetes or type 2 diabetes
  2. Presence of clinically significant neuropathy, (Dyck stage >2b) defined by abnormal neurologic testing (neurologic physical exam, nerve conduction, autonomic and quantitative sensory tests)
  3. History of major macrovascular events such as myocardial infarction or stroke within the past 3 months
  4. Participation in another clinical trial concurrently or within 30 days prior to entry into this study.
  5. Uncontrolled or untreated hypothyroidism as evidenced by TSH concentrations >4.8 uU/ml
  6. Other serious medical conditions which, in the opinion of the investigator, would compromise the subject's participation in the study, including sensitivity to aspirin
  7. Abnormalities of liver function defined as any liver enzymes (AST, ALT, SGPT, SGOT) greater than 3 times the upper limit of normal
  8. History of NYHA Class IV congestive heart failure.
  9. Allergy to Niaspan or aspirin
  10. 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.
  11. Pregnancy or breastfeeding
  12. History of peptic ulcer disease

  13. Current history of smoking

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Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930839


Locations
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United States, Virginia
Eastern Virgnia Medical School, Strelitz Diabetes Center
Norfolk, Virginia, United States, 23510f
Sponsors and Collaborators
Eastern Virginia Medical School
Abbott
Investigators
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Principal Investigator: Aaron I Vinik, MD, PhD Eastern Virginia Medical School, Strelitz Diabetes Center
More Information
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Responsible Party: Aaron I. Vinik, MD, PhD, Eastern Virginia Medical School, Strelitz Diabetes Center
ClinicalTrials.gov Identifier: NCT00930839    
Other Study ID Numbers: A10-597
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: March 10, 2010
Last Verified: March 2010
Keywords provided by Eastern Virginia Medical School:
Niacin
Prostaglandin D2
Flushing
Nicotinic acid stimulated release of prostaglandin D2
Additional relevant MeSH terms:
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Flushing
Skin Manifestations
Aspirin
Niacin
Nicotinic Acids
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
 Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients