Status:
COMPLETED
Role of Prostaglandins on Niacin-Induced Flushing
Lead Sponsor:
Eastern Virginia Medical School
Collaborating Sponsors:
Abbott
Conditions:
Flushing
Eligibility:
All Genders
30-80 years
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...
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 sk...
Eligibility Criteria
Inclusion
- Healthy controls ages 30-80
Exclusion
- 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
- \-
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00930839
Start Date
March 1 2009
End Date
February 1 2010
Last Update
March 10 2010
Active Locations (1)
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1
Eastern Virgnia Medical School, Strelitz Diabetes Center
Norfolk, Virginia, United States, 23510f