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

Sponsor
The Catholic University of Korea (Other)
Overall Status
Completed
CT.gov ID
NCT02056366
Collaborator
(none)
91
Enrollment
3
Locations
2
Arms
44
Duration (Months)
30.3
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: α-lipoic acid
 Phase 4

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
Actual Enrollment :
91 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: α-lipoic acid

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

Drug: α-lipoic acid
α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks
Other Names:
  • Neuropaid OD Tablet

    		•
    No Intervention: No treatment group

    No Intervention

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy [up to 24weeks]

      Check the Autonomic Nerve System(ANS) function 5 test

    Other Outcome Measures

    1. Number of Patients with Adverse events as a Measure of Safety [up to 24weeks]

      Check the Number of Adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Catholic University of Korea Seoul Korea, Republic of 137-701
    2 Eulji General Hospital Seoul Korea, Republic of
    3 Sejong General Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • The Catholic University of Korea

    Investigators

    • Principal Investigator: Bong Yun Cha, MD, PhD, The Catholic University of Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Hwa Kim, Professor, The Catholic University of Korea
    ClinicalTrials.gov Identifier:
    NCT02056366
    Other Study ID Numbers:
    • ALA_IIT01
    First Posted:
    Feb 6, 2014
    Last Update Posted:
    Feb 6, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Chong Hwa Kim, Professor, The Catholic University of Korea
    Cardiac Autonomic Neuropathy
    Additional relevant MeSH terms:
    Peripheral Nervous System Diseases
    Nervous System Diseases
    Thioctic Acid

    Study Results

    No Results Posted as of Feb 6, 2014