Month | |||||
---|---|---|---|---|---|
Examination | 0 | 3 | 6 | 9 | 12 |
Inclusion-/exclusion criteriaa | X | ||||
Informed consenta | X | ||||
Randomisation | X | ||||
Sociodemographic data | X | ||||
Size | X | ||||
Weight, waist circumference, blood pressure, heart frequency | X | X | X | X | X |
Bio-Impedance-Analysis | X | X | X | X | X |
Laboratory findings: | |||||
Electrolytes (Ca, K, Cl, Mg, Na) | X | X | |||
Liver enzymes (ASAT, ALAT, GGT, ALP, Bilirubin) | X | X | |||
Kidney (Crea, Urea, Uric acid) | X | X | |||
Blood count (Ery, Leuco, Ptl, Hk, Hb) | X | X | |||
TSH (basal) | X | X | |||
Fasten glucose | X | X | X | ||
Trigycerides | X | X | X | ||
Total cholesterol | X | X | X | ||
HDL-/LDL-Cholesterol | X | X | X | ||
Adverse events/effects | X | X | X | X |