| Baseline | Post-Intervention (16 weeks) | |||||
---|---|---|---|---|---|---|---|
Assessment | Screening | Day 0 | Day 1 | Day 2 | Day 3-5 | Day 112 | Day 113 |
Chart Review | x | Â | Â | Â | Â | Â | Â |
Patient Approached | x | Â | Â | Â | Â | Â | Â |
Informed Consent | x | Â | Â | Â | Â | Â | Â |
Outcome Assessments | Â | Â | Â | Â | Â | Â | Â |
Patient-reported outcomes | Â | x | Â | Â | Â | Â | Â |
Blood draw | Â | x | Â | Â | Â | x | Â |
Oral Glucose Test | Â | x | Â | Â | Â | x | Â |
Endothelial Function | Â | x | Â | Â | Â | x | Â |
VO2peak | Â | x | Â | Â | Â | x | Â |
Echocardiogram | Â | x | Â | Â | Â | x | Â |
Muscle biopsy | Â | Â | x | Â | Â | Â | x |
Repeat VO2peak | Â | Â | Â | x | Â | Â | Â |
Randomization | Â | Â | Â | x | Â | Â | Â |
Intervention initiation | Â | Â | Â | Â | x | Â | Â |