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

Phase 4

Completed

• Conditions: Cardiac Autonomic Neuropathy; Type 2 Diabetes
• Interventions: Drug: α-lipoic acid

• Registration Number: NCT02056366
• Lead Sponsor: The Catholic University of Korea

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)

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-02
• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-02-04
• Last Update Submitted: 2014-02-04
• Study First Posted: 2014-02-06
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
α-lipoic acid	α-lipoic acid	α-lipoic acid PO medication, 600mg per day, for 6weeks α-lipoic acid PO medication, 1200mg per day, for 6weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Eulji General Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of

Sejong General Hospital; 🇰🇷 Seoul, Korea, Republic of