What question did this study set out to answer?

To assess the efficacy and safety of oral antioxidant treatment with alpha-lipoic acid (ALA) in non-insulin-dependent diabetes mellitus (NIDDM) patients diagnosed with cardiac autonomic neuropathy.

March 1, 1997Diabetes Care

Effects of Treatment With the Antioxidant α-Lipoic Acid on Cardiac Autonomic Neuropathy in NIDDM Patients: A 4-month randomized controlled multicenter trial (DEKAN Study)

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Why the study?

Does oral alpha-lipoic acid improve heart rate variability in NIDDM patients with cardiac autonomic neuropathy?

Population

73 NIDDM patients with cardiac autonomic neuropathy (CAN) and reduced heart rate variability (HRV)

Comparison

Alpha-lipoic acid 800 mg oral daily for 4 months vs Matching placebo for 4 months

Design

RCT, randomly assigned, double-blind placebo-controlled

Follow-up

4 months

Authors

DZDan ZieglerElectrophysiology HSHelmut SchatzZahnklinik Bochum FCFrank ConradKonrad-Adenauer-Stiftung

Discussion

Member takes

Implication

ALA modestly improves HRV in diabetic CAN; extends autonomic data and supports larger outcome trials.

Key Points

To assess the efficacy and safety of oral antioxidant treatment with alpha-lipoic acid (ALA) in non-insulin-dependent diabetes mellitus (NIDDM) patients diagnosed with cardiac autonomic neuropathy.
Conducted a randomized, double-blind, placebo-controlled multicenter trial (DEKAN Study) in NIDDM patients exhibiting reduced heart rate variability (HRV).
Assigned patients to receive daily oral administration of either 800 mg ALA (n = 39) or placebo (n = 34) over a 4-month period.
Evaluated resting HRV parameters—including root mean square successive difference (RMSSD), coefficient of variation, low-frequency (LF) power, and high-frequency (HF) power—alongside cardiovascular autonomic symptoms and adverse events.
RMSSD increased by a median of 1.5 ms (-37.6 to 77.1) in the ALA group compared with a reduction of -0.1 ms (-19.2 to 32.8) in the placebo group (P < 0.05).
Spectral power in the LF band increased by 0.06 bpm² (-0.09 to 0.62) with ALA versus a decline of -0.01 bpm² (-0.48 to 1.86) with placebo (P < 0.05), alongside nonsignificant trends favoring ALA for coefficient of variation (P = 0.097) and HF power (P = 0.094).
Changes in cardiovascular autonomic symptoms and rates of adverse events did not differ significantly between treatment arms, with 17 dropouts recorded overall (ALA n = 10; placebo n = 7).

Structured PICO

Does oral alpha-lipoic acid improve heart rate variability in NIDDM patients with cardiac autonomic neuropathy?

Population

73 NIDDM patients with cardiac autonomic neuropathy (CAN) and reduced heart rate variability (HRV)

Intervention

Alpha-lipoic acid (ALA) 800 mg oral daily for 4 months

Comparator

Matching placebo for 4 months

Outcome

Parameters of heart rate variability (HRV) at rest, including coefficient of variation (CV), root mean square successive difference (RMSSD), and spectral power in the low-frequency (LF) and high-frequency (HF) bands at 4 monthssurrogate

Oral treatment with 800 mg/day of alpha-lipoic acid for 4 months slightly improves heart rate variability in NIDDM patients with cardiac autonomic neuropathy.

Limitations

High dropout rate (17 of 73 patients dropped out)

Cite This Study

Ziegler et al. (1997) studied this question.

synapsesocial.com/papers/6a867dce33f8e26b57db0698 https://doi.org/10.2337/diacare.20.3.369

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Effects of Treatment With the Antioxidant α-Lipoic Acid on Cardiac Autonomic Neuropathy in NIDDM Patients: A 4-month randomized controlled multicenter trial (DEKAN Study)

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Effects of Treatment With the Antioxidant α-Lipoic Acid on Cardiac Autonomic Neuropathy in NIDDM Patients: A 4-month randomized controlled multicenter trial (DEKAN Study)

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

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