The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy (CANON)
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ClinicalTrials.gov Identifier: NCT02056366 |
Recruitment Status :
Completed
First Posted : February 6, 2014
Last Update Posted : February 6, 2014
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Condition or disease | Intervention/treatment | Phase |
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Type 2 Diabetes Cardiac Autonomic Neuropathy | Drug: α-lipoic acid | Phase 4 |
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)
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 91 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: α-lipoic acid
α-lipoic acid PO medication, 600mg per day, for 6weeks α-lipoic acid PO medication, 1200mg per day, for 6weeks
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Drug: α-lipoic acid
α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks
Other Name: Neuropaid OD Tablet |
No Intervention: No treatment group
No Intervention
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- Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy [ Time Frame: up to 24weeks ]check the Heart rate variability(HRV) Index
- Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy [ Time Frame: up to 24weeks ]Check the Autonomic Nerve System(ANS) function 5 test
- Number of Patients with Adverse events as a Measure of Safety [ Time Frame: up to 24weeks ]Check the Number of Adverse events

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056366
Korea, Republic of | |
The Catholic University of Korea | |
Seoul, Korea, Republic of, 137-701 | |
Eulji General Hospital | |
Seoul, Korea, Republic of | |
Sejong General Hospital | |
Seoul, Korea, Republic of |
Principal Investigator: | Bong Yun Cha, MD, PhD | The Catholic University of Korea |
Responsible Party: | Chong Hwa Kim, Professor, The Catholic University of Korea |
ClinicalTrials.gov Identifier: | NCT02056366 |
Other Study ID Numbers: |
ALA_IIT01 |
First Posted: | February 6, 2014 Key Record Dates |
Last Update Posted: | February 6, 2014 |
Last Verified: | February 2014 |
Cardiac Autonomic Neuropathy |
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