The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy

The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy by Comparing the Change of HRV Index & ANS Function:A 6month Multicenter, Randomized, Open Label Clinical Trial CANON Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02056366

Acronym

CANON

Enrollment

Registered

2014-02-06

Start date

2010-01-31

Completion date

2013-09-30

Last updated

2014-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Autonomic Neuropathy, Type 2 Diabetes

Keywords

Cardiac Autonomic Neuropathy

Brief summary

The purpose of this study is to see if it is safe and effective to give alpha lipoic acid in people with cardiac autonomic neuropathy(CAN). Cardiac autonomic neuropathy(CAN) affects the nerves that control heart rate and blood flow to the heart in people with diabetes. CAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart.

Detailed description

Study type : Interventional Study Design : Allocation: Randomized Control: no treatment Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment Primary Outcome Measures : Heart rate variability(HRV) Index Secondary Outcome Measures : Autonomic Nerve System(ANS) function 5 test, EuroQoL 5-Dimension Questionnaire(EQ-5D)

Interventions

DRUGα-lipoic acid

α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

: * Established Cardiac Autonomic Neuropathy in type 2 diabetes. * aged 20 years to 80 years * Capable of giving informed consent

Exclusion criteria

: * History of other significant disease such as the nerve system (Parkinson's disease, epilepsy, multiple sclerosis), hepatic disease, hypothyroid, etc Other medical condition or treatment likely to affect the autonomic nerve system * HbA1C \> 11% * Not controlled hypertension (SBP≥160mmHg, DBP≥100mmHg) * Diagnosed ketoacidosis within 4 weeks * Unstable cardiac disease (unstable angina or myocardial infarction ) * Pregnancy * Involvement in other clinical trial in last 4 weeks * Known or suspected sensitivity to trial products

Design outcomes

Primary

Measure	Time frame	Description
Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy	up to 24weeks	check the Heart rate variability(HRV) Index

Secondary

Measure	Time frame	Description
Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy	up to 24weeks	Check the Autonomic Nerve System(ANS) function 5 test

Other

Measure	Time frame	Description
Number of Patients with Adverse events as a Measure of Safety	up to 24weeks	Check the Number of Adverse events

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026