| Outcome Measures: |
Primary: HbA1c - difference between final visit and baseline. | Secondary: Absolute HbA1c|Number of mild and severe hypoglycaemia with or without measurements of blood-glucose.|Insulin-dose|The following parameters are measured at baseline and at the final visit after 12 months of intervention:|Plasma-PAI-antigen and -activity, t-PA-antigen- and activity.|Plasma-fibrinogen|Serum-albumin|Markers of endothelial dysfunction: Von Willebrand Factor, ICAM, VCAM, Amadori-protein, selectin and endothelin.|Plasma-homocysteine|Asymmetric DiMethylArginine - ADMA|Urine-albumin-excretion in three 24 hour urine-collections|Blood-pressure in the sitting position after 10 minutes of rest.|Fasting lipid-profile (total-cholesterol, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol and triglycerides), small-dense-LDL, Lp(a) and Apo-B100.|Weight, BMI and Waist-hip-ratio|White blood-cell-count, hs-CRP, Interleukin-6 and TNF-alfa.|Serum-creatinine, sodium, potassium, ASAT, alkaline phosphatase, Factor 2, 7, 10, Cobalamin, Erythrocyte-folate and Haemoglobin-concentration.|Extra blood- and urine-samples will be stored at -80 degrees Celsius for potential extra analyses after closure of the study. DNA will be stored for later pharmaco-genetic analysis.
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