NCT02056366

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: The Catholic University of Korea · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Type 2 Diabetes
• Cardiac Autonomic Neuropathy

Interventions

Type	Name	Description
DRUG	α-lipoic acid	α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2014-02-06
• Last updated: 2014-02-06

Locations

3 sites across 1 country: South Korea