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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Type 2 Diabetes, Cardiac Autonomic Neuropathy

Intervention / Treatment
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* Drug: α-lipoic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: α-lipoic acid<br>α-lipoic acid PO medication, 600mg per day, for 6weeks α-lipoic acid PO medication, 1200mg per day, for 6weeks | Drug: α-lipoic acid<br>* α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks<br>* Other names: Neuropaid OD Tablet;|
| No Intervention: No treatment group<br>No Intervention | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Autonomic Neuropathy