Documentation/Investigation | Baseline | 12 wk | 6 mo | 1 yr | 2 yr | 3 yr | 4 yr |
---|---|---|---|---|---|---|---|
Clinical examination and medical history | x | ||||||
Information on data protection | x | ||||||
Blood pressure, heart rate | x | x | x | x | x | x | x |
Physical examination: height, weight, waist and hip circumference | x | x | x | x | x | ||
Laboratory screening (central laboratory): Blood glucose, HbA1c | x | x | x | x | x | x | x |
Laboratory values: hsCRP, total cholesterol, LDL-C, HDL-C, TG, cystatin C, potassium, albumin, OGTT | x | x | x | x | x | ||
ABPM (optional) | x | x | x | x | x | ||
AE, SAE | x | x | x | x | x | x |