Role of Prostaglandins on Niacin-Induced Flushing

Completed

Conditions studied: Flushing

In brief

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.

Key facts

Study ID

NCT00930839

Run by

Eastern Virginia Medical School

People needed

30

Starts

2009-03-01

Expected to finish

2010-02-01

Last updated by the study team

2010-03-10

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy controls ages 30-80

You may not qualify if…

• 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

Where it is running

• Eastern Virgnia Medical School, Strelitz Diabetes Center — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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