| Follow-up | |||
---|---|---|---|---|
Visit Number | 1 | 2 | 3–4–5... | Final visit |
Month | 0 | 3 | 6-month intervals | Â |
Inclusion/Exclusion criteria | x | Â | Â | Â |
Informed Consent | x | Â | Â | Â |
Medical history | x | Â | Â | Â |
Concomitant Medication | x | x | x | x |
Weight | x | Â | x | x |
Height | x | Â | Â | Â |
Waist circumference | x | Â | x | x |
Blood pressure/Heart rate | x | Â | x | x |
HbA1c | x | Â | x | x |
AST, ALT | x | Â | x | x |
Creatinine | x | Â | x | x |
Microlbuminuria | x | Â | x | x |
Albumin/creatinine ratio | x | Â | x | x |
Total cholesterol, HDL cholesterol, Triglycerides | x | x | x | x |
Adverse events | Â | x | x | x |
Compliance | Â | x | x | x |
End-point verification | Â | x | x | x |