1Division of Endocrinology and Metabolism, Department of Internal Medicine, Sejong General Hospital, Bucheon, Korea.
2Division of Endocrinology and Metabolism, Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, Korea.
3Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Copyright © 2017 Korean Diabetes Association
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
CONFLICTS OF INTEREST: This trial is supported by grants from the Chong Kun Dang Pharmaceuticals Korea Co., Ltd., Seoul, Republic of Korea.
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 | - |
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 |
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 |
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 |
Values are presented as mean±standard deviation. BMI, body mass index; HbA1c, glycosylated hemoglobin; SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate; HDL-C, high density lipoprotein cholesterol; LDL-C, low density lipoprotein cholesterol.
Values are presented as mean±standard deviation. BMI, body mass index; HbA1c, glycosylated hemoglobin; SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate; HDL-C, high density lipoprotein cholesterol; LDL-C, low density lipoprotein cholesterol.
ALA, α-lipoic acid; SD, standard deviation; HR, heart rate; SDNN, standard deviation of RR intervals; RMSSD, root mean square of successive differences; LF, low-frequency component; HF, high-frequency component.
ALA, α-lipoic acid; SD, standard deviation; SBP, systolic blood pressure; DBP, diastolic blood pressure.