|
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
|