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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| α-lipoic acid | Active Comparator | α-lipoic acid PO medication, 600mg per day, for 6weeks α-lipoic acid PO medication, 1200mg per day, for 6weeks |
|
| No treatment group | No Intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| α-lipoic acid | Drug | α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Adverse events as a Measure of Safety | Check the Number of Adverse events | up to 24weeks |
Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Bong Yun Cha, MD, PhD | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea | Seoul | Seoul | 137-701 | South Korea | ||
| Eulji General Hospital |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Seoul |
| Seoul |
| South Korea |
| Sejong General Hospital | Seoul | Seoul | South Korea |
| D004700 | Endocrine System Diseases |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |