Role of Prostaglandins on Niacin-Induced Flushing

NCT00930839 | Completed

• 1 other identifier: A10-597
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Flushing

Keywords

Niacin; Prostaglandin D2; Flushing; Nicotinic acid stimulated release of prostaglandin D2

Outcome Measures

Primary Outcomes (1)

• The primary efficacy measures are skin perfusion measurements and neurological measures.

  30 minutes after administration of Niacin

Secondary Outcomes (1)

• Secondary measures include blood chemistries

  15-30 min serial measurements

Study Arms (1)

Controls

Normal, healthy controls, males and females, ages 30-80

Drug: Niacin and aspirin

Interventions

Niacin and aspirin DRUG

1000 mg Niacin, 325 mg aspirin

Also known as: Niaspan, Nicotinic acid

Controls

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal, healthy control subjects, males and females, ages 30-80

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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• Abbott: collaborator

Study Sites (1)

Eastern Virgnia Medical School, Strelitz Diabetes Center

Norfolk, Virginia, 23510f, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin biopsies and serum

MeSH Terms

Conditions

Flushing

Interventions

Niacin; Aspirin

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Aaron I Vinik, MD, PhD

  Eastern Virginia Medical School, Strelitz Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2009
• First Posted: July 2, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 10, 2010

Record last verified: 2010-03

Locations

US (1)