Thiazolidinedione Intervention With Vitamin D Evaluation

Exclusion Criteria

• •Type 1 diabetes
• •Current need for insulin treatment
• •Symptomatic hyperglycemia requiring immediate therapy in the judgment of the physician
• •An acute cardiovascular event within 30 days prior to randomization
• •Symptomatic heart failure (i.e. New York Heart Association class II or higher) or any episode of previous pulmonary edema or known ejection fraction \< 0.4 or current use of loop diuretics
• •Any fracture within the past 1 year
• •Currently planned coronary, carotid or peripheral artery revascularization or cardiac valve surgery
• •Coronary, carotid or peripheral artery revascularization within the 4 years prior to screening in the absence of angina, MI, or stroke in the intervening period
• •End stage renal disease requiring renal replacement therapy
• •Receiving drug therapy to treat liver disease
• •A diagnosis of cancer (other than superficial squamous, basal cell skin cancer, or adequately treated cervical carcinoma in situ) in the past 3 years or current treatment for the active cancer (other than prophylactic)
• •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level \> 2.5 times the upper limit of normal
• •A prior heart transplant or awaiting a heart transplant
• •Previous or current hypercalcemia, hyperparathyroidism, osteomalacia or other contraindication for vitamin D therapy
• •Regular use of or indication for greater than 400IU of vitamin D daily
• •Clinically or medically unstable with expected survival \< 1 year
• •Unwillingness to permit sites to contact their primary physicians to communicate information about the study and the participant's data
• •Any other factor likely to limit protocol compliance or reporting of adverse events
• •Inability to discontinue a TZD (if taking one) in the judgement of the physician/investigator
• •Contraindications to or history of hypersensitivity to the investigational products
• •History of renal stones within the past 2 years
• •Participation in another clinical trial of an investigational agent