Visit | Screen | Wk 1 | Wk 4 | Wk 8 | Wk 12 | Wk 16 | Wk 20 | Wk 24 | EP 12 | EP 24 | EP 36 | EP 48 | EoS |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Informed consent | X | X | |||||||||||
Demography and History | X | ||||||||||||
Physical examination | X | X | X | X | X | X | X | X | X | ||||
Vital signs | X | X | X | X | X | X | X | X | X | X | X | X | X |
Weight & waist | X | X | X | X | X | X | X | X | X | X | X | X | X |
Haematology/Biochemistry | X | X | X | X | X | X | X | X | X | X | X | X | X |
Urinalysis | X | X | X | X | X | X | X | X | X | X | X | X | X |
12-lead ECG | X | X | X | X | X | X | X | X | X | ||||
IMP accountability | X | X | X | X | X | X | X | X | X | X | X | ||
Fasting glucose profile | X | X | X | X | X | X | X | X | X | X | X | X | |
Adverse events | X | X | X | X | X | X | X | X | X | X | X | X | |
Concomitant medications | X | X | X | X | X | X | X | X | X | X | X | X | |
FibroScan | X | X | X | X | X | X | X | ||||||
Liver/Cardiac MRI | X | X | X | ||||||||||
Insulin clamp/Microdialysis | X | X | |||||||||||
Adipose tissue biopsy | X | X | |||||||||||
Metabolic syndrome parameter | X | X | X | X | X | X | X | ||||||
Biomarkers | X | X | X | X | X | X | X | X | X | X | X |