| Outcome Measures: |
Primary: Change in HbA1c, Assess change in HbA1c, Baseline, 6 and 12 months | Secondary: Changes in fasting glucose, Determine the change in fasting glucose levels, Baseline, 6 and 12 months|Change in the 2-hour oral glucose tolerance curve, Determine the change from baseline in the results of the 2-hour oral glucose tolerance curve, Baseline, 6 and 12 months|Changes to HOMA-IR (Homeostatic model assessment and Insulin resistance, Determine change in HOMA-IR, Baseline, 6 and 12 months|Changes in insulin levels, Determine the changes in insulin levels, Baseline, 6 and 12 months|Changes in leptin levels, Determine the changes in leptin levels, Baseline, 6 and 12 months|Changes in adipokine levels, Determine the changes in adipokine levels, Baseline, 6 and 12 months|Changes in proinflammatory cytokine, Determine the changes in proinflammatory cytokine, Baseline, 6 and 12 months|Changes in levels of MCP-1 (monocyte chemoattractant protein 1), Determine the changes in levels of MCP-, Baseline, 6 and 12 months|Changes in nitric oxide levels, Determine changes in nitric oxide levels, Baseline, 6 and 12 months|Changes in C-reactive protein levels, Determine changes in C-reactive protein levels, Baseline, 6 and 12 months|Changes in body mass index, Determine changes in body mass index, Baseline, 6 and 12 months|Incidence of adverse events, Determine the incidence of adverse events that occurred during the study., Baseline, 6 and 12 months
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