Inflammation and the Metabolic Syndrome in Humans

Exclusion Criteria

• •1. Known atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease.
• •2. History of diabetes mellitus.
• •3. A plasma glucose greater than 200 mg/dL at the 2 hour blood draw of the oral glucose tolerance test.
• •4. History of a non-skin malignancy within the previous 5 years.
• •5. Renal insufficiency as defined by creatinine \>= 1.5 mg/dl at visit 1 (grade 1 of NIH's Common Toxicity Criteria (CTC), version 2.0, 4/30/99).
• •6. History of liver disease or ALT, AST, ALK Phosphatase or Gamma GT above normal limits as defined by HUP William Pepper Clinical Laboratory at visit 1.
• •7. Elevated (\> 1.5x ULN; grade 1, CTC, 4/30/99) Total Bilirubin or LDH at visit 1.
• •8. Men who consume \> 14 alcoholic drinks per week or \> 4 alcoholic drinks per occasion (AMA/NIAAA criteria for "at risk" usage levels).
• •9. Women who consume \> 7 alcoholic drinks per week or \> 3 alcoholic drinks per occasion (AMA/NIAAA criteria for "at risk" usage levels).
• •10. Total white blood cell count below normal limits as defined at HUP William Pepper Clinical Laboratory prior to the baseline visit.
• •11. Hemoglobin below normal limits (gender specific) as defined at HUP William Pepper Clinical Laboratory prior to the baseline visit.
• •12. Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator.
• •13. Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition or minor active infection.
• •14. History of HIV positive.
• •15. First degree family history of premature cardiovascular disease event (father or brother if diagnosed at before 55 years of age; mother or sister if diagnosed before 65 years of age).
• •16. Patients who have undergone any organ transplant.
• •17. Individuals who currently use tobacco products or have done so in the previous 30 days.
• •18. Treatment with aspirin, NSAIDs, COX-2 inhibitors, steroids or other immunomodulatory therapy 2 weeks prior to the screening visit
• •19. Treatment with statins, fibrates or niacin 4 weeks prior to the screening visit.
• •20. Current daily use of Vitamin C \> 1000 mg, Beta carotene \> 1000 IU, vitamin A \> 5000 IU, vitamin E \> 400 IU, and selenium \> 200 mcg.
• •21. Positive urine pregnancy at the screening visit.
• •22. Participation in another clinical trial within the previous 6 weeks prior to the screening visit.
• •23. Poorly controlled blood pressure (BP \> 160/100) or on any anti-hypertensive medications.
• •24. For subjects in non-metabolic syndrome groups; a diagnosis of metabolic syndrome using NCEP ATPIII criteria.
• •25. For subjects in "metabolic syndrome" group; an abnormal Bruce protocol cardiac exercise stress test.