Table 1

Clinical characteristics of the intention-to-treat population at baseline

ALAPlaceboP
n230224
Age (years)53.3 ± 8.353.9 ± 7.60.3607
Sex (% male)66.167.00.8430
BMI (kg/m2)29.7 ± 6.129.8 ± 6.10.9226
Heart rate (bpm)76.3 ± 12.374.6 ± 12.60.1603
Type 1/type 2 diabetes27.4 / 72.621.0 / 79.00.1111
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 treatment58.955.10.4170
HbA1c8.9 ± 1.88.8 ± 1.90.6354
Fasting blood glucose (mmol/L)11.1 ± 4.6810.9 ± 4.260.6529
Nephropathy11.712.00.5935
Retinopathy45.543.60.6833
Neuropathy stage 1/stage 2a11.3 / 88.79.8 / 90.20.6074
NIS-LL+7 (nds)17.1 ± 8.416.8 ± 8.00.6740
NIS (points)12.7 ± 8.612.2 ± 7.80.5062
NIS-LL (points)9.8 ± 5.69.5 ± 5.30.6087
Peroneal MNCV (m/s)38.5 ± 5.0338.1 ± 6.480.4957
Sural SNAP (µV)2.49 ± 3.382.43 ± 3.210.8387
Vibration perception threshold (JND)21.27 ± 3.1821.21 ± 3.520.8393
Cold detection threshold (JND)17.86 ± 5.1417.58 ± 5.330.5765
Heart rate deep breathing (bpm)7.26 ± 5.448.59 ± 6.590.0193
NSC weakness (number)0.06 ± 0.300.03 ± 0.230.2353
NSC weakness (severity)0.10 ± 0.560.04 ± 0.310.1613
TSS (points)2.4 ± 1.92.6 ± 1.80.2752
  • 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.