| Outcome Measures: |
Primary: Nitrotyrosine, The difference in the percent increase of the oxidative stress biomarker nitrotyrosine after stimulation with a standardized meal, Baseline, after 10 weeks, after 24 weeks | Secondary: Skin blood flow, Change in skin blood flow during stimulation by a standardized meal, Baseline, after 10 weeks, after 24 weeks|mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9), Biomarkers of sub-clinical inflammation and cardiovascular risk: Change in Macrophage activation, MAPK/eNOS production levels, adiponectin and hsCRP (after test meal) from baseline to endpoint, Baseline, after 10 weeks, after 24 weeks|Insulin, Change in Insulin and the ratio from baseline to endpoint, Baseline, after 10 weeks, after 24 weeks|HbA1c, Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint, Baseline, after 10 weeks, after 24 weeks|Fasting blood glucose, Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint, Baseline, after 10 weeks, after 24 weeks|Hypoglycemic events, Incidence of hypoglycemia from baseline to endpoint, Baseline, after 10 weeks, after 24 weeks|intact Proinsulin, Change in intact Proinsulin and the ratio from baseline to endpoint, Baseline, after 10 weeks, after 24 weeks
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