Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome

Inclusion Criteria:

• Hyperinsulinemia in the upper quartile of the non-diabetic population defined as ≥10 mU/mL (Framingham Data, oral communication, James Meigs, MD) or fasting glucose 110-126 mg/dL, plus two of the following: *Abdominal obesity defined by waist hip ratio > 0.90 for men and > 0.85 for women or *body mass index (BMI) > 30 kg/m2
• Dyslipidemia including serum triglycerides ≥150 mg/dl or serum HDL < 0.9 mmol/L for men (35 mg/dL) and < 1.0 mmol/L (39 mg/dL) for women
• Hypertension defined as blood pressure ≥ 140/90 or on medication

Exclusion Criteria:

• Positive PPD (≥ 5mm induration) on screening
• Current infection
• Therapy with glucocorticoid or immunosuppressant at time of recruitment or within past 3 months
• Reception of live vaccine within 1 week of recruitment
• History of blood dyscrasia including any kind of anemia, thrombocytopenia, pancytopenia. Women with a reversible cause of anemia that has resolved will be eligible.
• History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers who will be eligible)
• History of organ transplantation
• History of central nervous system (CNS) demyelinating disorder or any first degree relative with multiple sclerosis
• History of congestive heart failure (CHF) classes I-IV
• Current use of insulin, any oral anti-hyperglycemic agents, pentoxyfylline, beta-agonists
• Current use of fibrate or niacin
• Initiation of statin therapy within prior 6 weeks or expecting a change in statin dose over the upcoming 3 months
• Hemoglobin < 11 g/dl
• Positive pregnancy test
• Women of child-bearing potential not currently using non-hormonal birth control methods including barrier methods (intrauterine device [IUD], condoms, diaphragms) or abstinence
• Patients with known autoimmune or inflammatory conditions