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Clinical Trials/NCT02056366
NCT02056366
Completed
Phase 4

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

The Catholic University of Korea3 sites in 1 country91 target enrollmentStarted: January 2010Last updated:
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ConditionsType 2 DiabetesCardiac Autonomic Neuropathy
Interventionsα-lipoic acid

Overview

Phase
Phase 4
Status
Completed
Enrollment
91
Locations
3
Primary Endpoint
Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

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

Intervention: α-lipoic acid (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy(up to 24weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chong Hwa Kim

Professor

The Catholic University of Korea

Study Sites (3)

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