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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056366
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Chong Hwa Kim, The Catholic University of Korea

Study Description
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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
Type 2 Diabetes Cardiac Autonomic Neuropathy 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
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Study Type : Interventional  (Clinical Trial)
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 : January 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

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Arms and Interventions
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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 Name: Neuropaid OD Tablet
No Intervention: No treatment group
No Intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy [ Time Frame: 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 [ Time Frame: up to 24weeks ]
    Check the Number of Adverse events


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056366


Locations
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Korea, Republic of
The Catholic University of Korea
Seoul, Korea, Republic of, 137-701
Eulji General Hospital
Seoul, Korea, Republic of
Sejong General Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
The Catholic University of Korea
Investigators
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Principal Investigator: Bong Yun Cha, MD, PhD The Catholic University of Korea
More Information
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Responsible Party: Chong Hwa Kim, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02056366    
Other Study ID Numbers: ALA_IIT01
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014
Keywords provided by Chong Hwa Kim, The Catholic University of Korea:
Cardiac Autonomic Neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
 Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances