Table 2.
Primary and secondary outcomes.
| N | Event | OR (95% CI) | p Value | |
|---|---|---|---|---|
| Primary outcomes | ||||
| All-cause mortality | 14 | 2 | 0.244 | |
| Treatment | 7 | 0 | 0.15 (0.01–3.71) | |
| Control | 7 | 2 | 1.0 (ref.) | |
| CV events | 14 | 1 | 0.470 | |
| Treatment | 7 | 0 | 0.29 (0.01–8.39) | |
| Control | 7 | 1 | 1.0 (ref.) | |
| Infection events | 14 | 5 | 0.579 | |
| Treatment | 7 | 3 | 1.88 (0.20–17.27) | |
| Control | 7 | 2 | 1.0 (ref.) | |
| Secondary outcomes | Treatment (n = 6) | Control (n = 5) | p value | |
| HbA1c | 6.6 ± 1.3 | 5.8 ± 1.2 | 0.401 | |
| Cardiac function | ||||
| LVEF | 61 ± 17 | 61 ± 7 | 0.923 | |
| LV mass | 281 ± 70 | 266 ± 58 | 0.795 | |
| Peripheral vessel | ||||
| Right ABI | 1.1 ± 0.2 | 1.1 ± 0.1 | 0.831 | |
| Left ABI | 1.0 ± 0.2 | 1.1 ± 0.1 | 0.097 | |
| Right PWV | 16.6 ± 3.9 | 14.6 ± 4.3 | 0.523 | |
| Left PWV | 15.4 ± 4.2 | 15.2 ± 4.7 | 0.945 | |
Statistics by Mann–Whitney U test. Significance level set at p-value < 0.05. LVEF: left ventricular ejection fraction. LV: left ventricular. ABI: ankle-brachial index PWV: pulse wave velocity.