Diabetes Metab J.  2017 Aug;41(4):275-283. 10.4093/dmj.2017.41.4.275.

Effects of High-Dose α-Lipoic Acid on Heart Rate Variability of Type 2 Diabetes Mellitus Patients with Cardiac Autonomic Neuropathy in Korea

• Lee SJ
• Jeong SJ
• Lee YC
• Lee YH
• Lee JE
• Kim CH
• Min KW
• Cha BY

• KMID: 2392468
• DOI: http://doi.org/10.4093/dmj.2017.41.4.275

Abstract

BACKGROUND
Diabetic cardiac autonomic neuropathy (CAN) is one of the important complications of diabetes. It is characterized by reduced heart rate variability (HRV).
METHODS
In this randomized, double-blind, placebo-controlled, multicenter trial, 75 patients were randomly assigned to one of two groups. One group (n=41) received α-lipoic acid (ALA) at an oral dose of 600 mg/day for the first 12 weeks and then 1,200 mg/day for the next 12 weeks. The other group (n=34) received placebo treatment for 24 weeks. CAN was assessed by measuring HRVs in people with diabetes.
RESULTS
Most of the baseline measures for HRVs were similar between the ALA and placebo groups. Although there were no statistically significant HRV changes in the ALA group compared to the placebo group after 24 weeks of trial, we found a positive tendency in some of the HRV parameters of the ALA group. The standard deviations of normal-to-normal RR intervals in the standing position increased by 1.87 ms in the ALA group but decreased by −3.97 ms in the placebo group (P=0.06). The power spectrum of the low frequency (LF) band in the standing position increased by 15.77 ms² in the ALA group, whereas it declined by −15.04 ms² in the placebo group (P=0.08). The high frequency/LF ratio in the upright position increased by 0.35 in the ALA group, whereas it declined by −0.42 in the placebo group (P=0.06). There were no differences between the two groups regarding rates of adverse events.
CONCLUSION
Although a slight improvement tendency was seen in HRV in the ALA group, there were no statistically significant HRV changes in the ALA group compared to the placebo group after 24 weeks of trial. However, the high oral dose of ALA was well-tolerated.

Keyword

Cardiac autonomic neuropathy; Diabetes; Heart rate variability; Thioctic acid

MeSH Terms

Diabetes Mellitus, Type 2*
Heart Rate*
Heart*
Humans
Korea*
Multicenter Studies as Topic
Posture
Thioctic Acid
Thioctic Acid

Figure

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  Fig. 1 Study enrollment and follow-up.

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