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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls | Normal, healthy controls, males and females, ages 30-80 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niacin and aspirin | Drug | 1000 mg Niacin, 325 mg aspirin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy measures are skin perfusion measurements and neurological measures. | 30 minutes after administration of Niacin |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary measures include blood chemistries | 15-30 min serial measurements |
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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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Normal, healthy control subjects, males and females, ages 30-80
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| Name | Affiliation | Role |
|---|---|---|
| Aaron I Vinik, MD, PhD | Eastern Virginia Medical School, Strelitz Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Virgnia Medical School, Strelitz Diabetes Center | Norfolk | Virginia | 23510f | United States |
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| ID | Term |
|---|---|
| D005483 | Flushing |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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Skin biopsies and serum
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |