Melatonin and the Metabolic Syndrome

Exclusion Criteria

• •1. Inability to understand informed consent and to cooperate with study procedures.
• •2. Supplemental intake of melatonin.
• •3. Current smoking.
• •4. Current use of calcium channel blockers.
• •5. Current, planned, or recent (12 months) participation in another clinical trial.
• •6. Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the next 6 months.
• •7. Presence of any of the following diagnosed health conditions:
• •* Active malignancy other than nonmelanoma skin cancer (current therapy for this malignancy,diagnosis within five years of enrollment, recurrence within five years of enrollment, or metastasis)
• •* Uncontrolled hypothyroidism or hyperthyroidism
• •* Recent (\< 1 year ago) history of heart attack, bypass surgery, angioplasty, or stroke
• •* Heart failure (New York Heart Association functional class 3 or 4)
• •* On renal dialysis
• •* Immunosuppressive therapy (systemic corticosteroids, azathioprine, methotrexate, cyclophosphamide,
• •* etc.) or an immunodeficiency syndrome
• •* Narcotic or alcohol dependence
• •* Obstructive sleep apnea (OSA) , defined either by previous diagnosis (with or without use of nasal CPAP), or by a score of 0.80 or higher on the MAP (Multivariate Apnea Prediction), a validated screening algorithm with high positive and negative predictive value for identifying OSA.
• •8. Shift-workers.