Fig. 1Study enrollment and follow-up.
Table 1Demographic and clinical baseline characteristics of the patients
Characteristic |
α-Lipoic acid |
Placebo |
P value |
No. of patients |
46 |
45 |
- |
Sex, male/female |
27/19 |
20/25 |
- |
Age, yr |
64.37±7.80 |
62.40±9.10 |
0.270 |
BMI, kg/m2
|
25.38±3.29 |
25.64±2.86 |
0.723 |
Duration of diabetes, yr |
13.84±9.11 |
11.37±8.82 |
0.240 |
HbA1c, % |
7.54±1.12 |
7.35±1.04 |
0.393 |
SBP, mm Hg |
124.26±12.45 |
125.76±13.89 |
0.590 |
DBP, mm Hg |
73.24±8.57 |
75.09±8.52 |
0.305 |
Mean HR, beat/min |
72.54±7.91 |
70.60±7.35 |
0.228 |
Lipid profile, mg/dL |
|
|
|
Total cholesterol |
162.33±36.69 |
163.42±42.65 |
0.896 |
Triglyceride |
145.67±100.67 |
133.56±79.97 |
0.527 |
HDL-C |
48.09±12.52 |
45.51±11.03 |
0.301 |
LDL-C |
84.03±35.22 |
87.01±31.99 |
0.705 |
No. of patients on the medication |
|
|
|
Oral anti-hypertensives |
33 |
26 |
- |
Statin |
27 |
26 |
- |
Insulin |
13 |
10 |
- |
Oral anti-diabetes |
31 |
24 |
- |
Table 2Demographic and clinical characteristics of the patients after 24 weeks of the study
Characteristic |
α-Lipoic acid |
Placebo |
P value |
No. of patients |
41 |
34 |
- |
Sex, male/female |
24/17 |
18/16 |
- |
Age, yr |
63.76±7.84 |
62.09±9.43 |
0.405 |
BMI, kg/m2
|
25.17±3.17 |
25.84±2.75 |
0.512 |
HbA1c, % |
7.64±1.02 |
7.65±1.04 |
0.262 |
SBP, mm Hg |
120.70±12.84 |
123.71±15.06 |
0.307 |
DBP, mm Hg |
78.02±10.14 |
76.78±10.69 |
0.570 |
Mean HR, beat/min |
74.30±9.58 |
73.71±9.72 |
0.770 |
Lipid profiles, mg/dL |
|
|
|
Total cholesterol |
161.23±32.49 |
164.32±41.55 |
0.685 |
Triglyceride |
146.46±86.74 |
141.64±82.47 |
0.314 |
HDL-C |
48.48±11.47 |
46.41±10.24 |
0.218 |
LDL-C |
82.43±34.82 |
88.41±36.48 |
0.642 |
Table 3Heart rate variability at baseline and changes after 24 weeks
Position |
Index |
Baseline |
Changes after 24 weeks |
ALA |
Placebo |
P value |
ALA |
Placebo |
P value |
No. of patient |
Mean±SD |
No. of patient |
Mean±SD |
t-test |
No. of patient |
Mean±SD |
Paired t-test |
No. of patient |
Mean±SD |
Paired t-test |
t-test |
Up-right |
Mean HR, beat/min |
36 |
78.94±8.88 |
30 |
77.20±8.66 |
0.425 |
36 |
1.31±9.04 |
0.392 |
28 |
2.43±7.06 |
0.080 |
0.591 |
SDNN, ms |
37 |
19.59±7.54 |
29 |
24.72±9.14 |
0.015 |
36 |
1.87±11.79 |
0.347 |
28 |
–3.97±12.64 |
0.108 |
0.061 |
RMSSD, ms |
38 |
14.05±8.23 |
32 |
15.95±9.13 |
0.362 |
34 |
0.87±8.44 |
0.553 |
31 |
0.47±10.17 |
0.799 |
0.864 |
LF, ms2
|
39 |
39.44±42.05 |
31 |
75.92±57.58 |
0.003 |
37 |
15.77±58.87 |
0.112 |
28 |
–15.04±82.26 |
0.342 |
0.083 |
HF, ms2
|
39 |
31.47±34.19 |
33 |
38.78±35.44 |
0.377 |
39 |
–1.58±32.44 |
0.763 |
28 |
8.14±49.87 |
0.395 |
0.371 |
LF/HF ratio |
38 |
1.98±1.53 |
31 |
2.19±1.69 |
0.587 |
37 |
0.35±1.60 |
0.195 |
29 |
–0.42±1.69 |
0.191 |
0.063 |
Supine |
Mean HR, beat/min |
35 |
72.37±7.22 |
31 |
71.42±8.37 |
0.621 |
36 |
1.31±9.04 |
0.392 |
28 |
2.43±7.06 |
0.080 |
0.591 |
SDNN, ms |
37 |
25.80±12.03 |
29 |
23.77±6.64 |
0.389 |
37 |
–0.61±9.93 |
0.710 |
28 |
–0.11±9.01 |
0.947 |
0.836 |
RMSSD, ms |
36 |
16.08±9.46 |
31 |
16.98±9.25 |
0.694 |
34 |
0.80±12.38 |
0.709 |
31 |
–3.18±9.50 |
0.072 |
0.154 |
LF, ms2
|
38 |
58.36±59.79 |
31 |
93.60±89.99 |
0.067 |
37 |
26.75±97.70 |
0.105 |
28 |
2.57±75.99 |
0.859 |
0.282 |
HF, ms2
|
38 |
50.94±58.93 |
31 |
46.37±34.42 |
0.690 |
38 |
22.16±85.75 |
0.120 |
31 |
–6.40±50.90 |
0.489 |
0.091 |
LF/HF ratio |
38 |
1.74±1.20 |
30 |
2.02±1.81 |
0.470 |
38 |
0.71±2.31 |
0.066 |
28 |
0.49±2.20 |
0.248 |
0.700 |
Table 4Autonomic nerve functions at baseline and changes after 24 weeks
Index |
Baseline |
Changes after 24 weeks |
ALA |
Placebo |
P value |
ALA |
Placebo |
P value |
No. of patient |
Mean±SD |
No. of patient |
Mean±SD |
t-test |
No. of patient |
Mean±SD |
Paired t-test |
No. of patient |
Mean±SD |
Paired t-test |
t-test |
30:15 Heart rate ratio with standing |
39 |
1.02±0.04 |
32 |
1.04±0.08 |
0.088 |
39 |
0.02±0.07 |
0.036 |
28 |
0.04±0.08 |
0.014 |
0.359 |
Valsalva ratio |
36 |
1.11±0.12 |
33 |
1.16±0.14 |
0.150 |
34 |
0.07±0.14 |
0.009 |
31 |
0.05±0.18 |
0.140 |
0.611 |
Beat to beat variation with deep breathing, ms |
38 |
10.32±4.59 |
29 |
10.83±6.54 |
0.721 |
38 |
4.53±8.70 |
0.003 |
24 |
2.13±6.96 |
0.148 |
0.259 |
Orthostasis blood pressure (SBP), mm Hg |
37 |
2.38±10.21 |
29 |
3.59±8.11 |
0.604 |
36 |
–4.39±10.03 |
0.013 |
27 |
0.63±9.44 |
0.732 |
0.048 |
Orthostasis blood pressure (DBP), mm Hg |
34 |
4.26±5.33 |
30 |
4.83±5.58 |
0.678 |
34 |
–2.35±5.62 |
0.020 |
25 |
–0.76±5.61 |
0.504 |
0.286 |
Hand grip blood pressure (SBP), mm Hg |
38 |
149.37±18.45 |
31 |
150.71±22.56 |
0.787 |
36 |
–1.17±21.09 |
0.742 |
28 |
3.36±19.89 |
0.380 |
0.386 |
Hand grip blood pressure (DBP), mm Hg |
38 |
94.53±13.28 |
31 |
92.84±16.39 |
0.638 |
36 |
–3.22±13.11 |
0.149 |
28 |
3.57±16.94 |
0.274 |
0.075 |