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

February 4, 2014 updated by: Chong Hwa Kim, The Catholic University of Korea

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Eulji General Hospital
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University of Korea
      • Seoul, Korea, Republic of
        • Sejong General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
Time Frame: up to 24weeks
check the Heart rate variability(HRV) Index
up to 24weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients with Adverse events as a Measure of Safety
Time Frame: up to 24weeks
Check the Number of Adverse events
up to 24weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 4, 2014

First Posted (Estimate)

February 6, 2014

Study Record Updates

Last Update Posted (Estimate)

February 6, 2014

Last Update Submitted That Met QC Criteria

February 4, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALA_IIT01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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