Visit | V0 | V1
Randomisation | T1 | V2 | T2 | V3 |
Time, weeks | −4±1 | 0±1 | 2±1 | 4±1 | 8±1 | 12±1 |
Inclusion/exclusion criteria | X | X | ||||
Medical history | X | |||||
Informed consent | X | |||||
Blood samples, non-fasting | X | X | ||||
Physical examination | X | X | ||||
Adverse events | X | X | X | X | X | |
Endpoints, main study | ||||||
82Rb-PET (primary endpoint) | X | X | ||||
Echocardiography | X | X | ||||
Ambulatory BP | X | X | ||||
Adipose tissue biopsy | X | X | ||||
Oral glucose tolerance test | X | X | ||||
Questionnaires | X | X | ||||
HRV | X | X | ||||
PWA | X | X | ||||
51Cr EDTA clearance | X | X | ||||
Body composition (DXA) | X | X | ||||
Blood samples, fasting | X | X | ||||
Urine samples, fasting | X | X | ||||
Endpoints, substudy | ||||||
Haemodynamics (key secondary endpoint) | X | X | ||||
Accelerometer | X | X |
X marks that the given examination will be performed at the specific visit.
BP, blood pressure; HRV, heart rate variability; PWA, pulse wave analysis; 82Rb-PET, Rubidium-82 position emission tomography.