| Outcome Measures: |
Primary: The difference in increase of retinal blood flow after flicker stimulation of retinal endothelial cells, Retinal capillary blood flow will be assessed using scanner laser doppler flowmetry., timepoint 0 and after 6 and 12 weeks | Secondary: Central vascular elasticity, Central arterial elasticity will be measured by Pulse wave velocity., timepoint 0 and after 6 and 12 weeks|Skin endothelial function and Skin oxygenation, Microvascular skin blood flow and postcapillary tissue oxygenation (sO2)will be measured., timepoint 0 and after 6 and 12 weeks|Blood glucose control, Fasting plasma glucose will be measured., timepoint 0 and after 6 and 12 weeks|Blood glucose control, HbA1c will be maesured., up to 2 weeks before baseline and after 6 and 12 weeks after baseline|Change of biomarkers of sub-clinical inflammation and cardiovascular risk, Biomarkers PAI-1, hsCRP, VCAM, E-selectin and ADMA will be measured., timepoint 0 and after 6 and 12 weeks|Change of biomarker of heart failure, NT-pro BNP will be measured., timepoint 0 and after 6 and 12 weeks|Insulin/ intact Proinsulin ratio, C-peptide, Insulin Intact Proinsulin and C-peptide will be maesured., timepoint 0 and after 6 and 12 weeks|Change of body weight, Body weight will be measured., up to 2 weeks before baseline and after 6 and 12 weeks after baseline|Safety evaluation, The safety evaluation includes: * Metabolic parameters indicating hepatic function (ALAT, ASAT, γ-GT) * Blood analysis (Alkaline Phosphatase, Blood cell count) * Change in pancreas function (Amylase, Lipase) * Change in renal function (Creatinine, Potassium) * Change in thyroid function (Calcitonin) * Vital signs (Blood Pressure, Radial Pulse, ECG) * β-HCG (only female patients of childbearing potential) * Adverse Events * Adverse Drug Reactions, up to 2 weeks before baseline and after 12 weeks post baseline
|
