Table 1.
Clinical characteristics of the intention-to-treat population at baseline
| ALA | Placebo | P | |
|---|---|---|---|
| n | 230 | 224 | |
| Age (years) | 53.3 ± 8.3 | 53.9 ± 7.6 | 0.3607 |
| Sex (% male) | 66.1 | 67.0 | 0.8430 |
| BMI (kg/m2) | 29.7 ± 6.1 | 29.8 ± 6.1 | 0.9226 |
| Heart rate (bpm) | 76.3 ± 12.3 | 74.6 ± 12.6 | 0.1603 |
| Type 1/type 2 diabetes | 27.4 / 72.6 | 21.0 / 79.0 | 0.1111 |
| Diabetes duration (years) | 13.3 (0.8–56.1) | 13.5 (0.9–46.7) | 0.4190 |
| Neuropathy duration (years) | 3.0 (0.0–25.4) | 3.2 (0.0–21.1) | 0.2588 |
| Insulin treatment | 58.9 | 55.1 | 0.4170 |
| HbA1c | 8.9 ± 1.8 | 8.8 ± 1.9 | 0.6354 |
| Fasting blood glucose (mmol/L) | 11.1 ± 4.68 | 10.9 ± 4.26 | 0.6529 |
| Nephropathy | 11.7 | 12.0 | 0.5935 |
| Retinopathy | 45.5 | 43.6 | 0.6833 |
| Neuropathy stage 1/stage 2a | 11.3 / 88.7 | 9.8 / 90.2 | 0.6074 |
| NIS-LL+7 (nds) | 17.1 ± 8.4 | 16.8 ± 8.0 | 0.6740 |
| NIS (points) | 12.7 ± 8.6 | 12.2 ± 7.8 | 0.5062 |
| NIS-LL (points) | 9.8 ± 5.6 | 9.5 ± 5.3 | 0.6087 |
| Peroneal MNCV (m/s) | 38.5 ± 5.03 | 38.1 ± 6.48 | 0.4957 |
| Sural SNAP (µV) | 2.49 ± 3.38 | 2.43 ± 3.21 | 0.8387 |
| Vibration perception threshold (JND) | 21.27 ± 3.18 | 21.21 ± 3.52 | 0.8393 |
| Cold detection threshold (JND) | 17.86 ± 5.14 | 17.58 ± 5.33 | 0.5765 |
| Heart rate deep breathing (bpm) | 7.26 ± 5.44 | 8.59 ± 6.59 | 0.0193 |
| NSC weakness (number) | 0.06 ± 0.30 | 0.03 ± 0.23 | 0.2353 |
| NSC weakness (severity) | 0.10 ± 0.56 | 0.04 ± 0.31 | 0.1613 |
| TSS (points) | 2.4 ± 1.9 | 2.6 ± 1.8 | 0.2752 |
Data are means ± SD, median (range), or %. P values derived from χ2 test for binary data and from t tests otherwise. JND, just noticeable difference; SNAP, sensory nerve action potential.