Role of Prostaglandins on Niacin-Induced Flushing

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eastern Virginia Medical School
• Collaborator: Abbott
• Treatments: Aspirin; Niacin; Niacinamide; Nicotinic Acids

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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