| Pre-randomization | Randomization | Post-randomization | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Test/action | Visit 1 | Visit 2 | Visit 3 | Visit 4 (wk 0) | Visit 5 (wk 2) | Visit 6 (wk 4) | Visit 7 (wk 8) | Visit 8 (wk 12) | Visit 9 (wk 16) | Visit 10 (wk 20) | Visit 11 (wk 24) | Visit 12 (wk 24) | Visit 13 (wk 30) | Visit 14 (wk 36) | Visit 15 (wk 42) | Visit 16 (wk 48) | Visit 17 (wk 48) | Visit 18 (wk 50) |
Clinical exam | x | Â | Â | Â | Â | Â | Â | x | Â | Â | x | Â | Â | x | Â | Â | x | Â |
Questionnaires | x | x | Â | Â | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | Â | Â | x | Â |
Activity monitor | x | Â | Â | Â | Â | Â | Â | x | Â | Â | x | Â | Â | x | Â | Â | x | Â |
Non-fasting blood tests | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | Â | Â | x | Â |
Fasting blood tests | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | Â | Â | x | Â |
HbA1c | x | Â | Â | Â | Â | Â | Â | x | Â | Â | x | Â | Â | x | Â | Â | x | Â |
Inflammatory markers | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | Â | Â | x | Â |
Urine albumin/creatinine ratio | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | Â | Â | x | Â |
Meal-stimulated C peptide | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | Â | Â | x | Â |
Fitness test | Â | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | x | Â | Â |
Nurse visit | Â | Â | Â | Â | x | Xa | x | x | Xa | x | Â | Â | Xa | x | Xa | Â | Xa | Â |
Focus group feedback | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | x |