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

Primary Purpose

Type 2 Diabetes, Cardiac Autonomic Neuropathy

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
α-lipoic acid
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Cardiac Autonomic Neuropathy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Catholic University of Korea
  • Eulji General Hospital
  • Sejong General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

α-lipoic acid

No treatment group

Arm Description

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

No Intervention

Outcomes

Primary Outcome Measures

Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
check the Heart rate variability(HRV) Index

Secondary Outcome Measures

Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
Check the Autonomic Nerve System(ANS) function 5 test

Full Information

First Posted
February 3, 2014
Last Updated
February 4, 2014
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02056366
Brief Title
The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy
Acronym
CANON
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 Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Cardiac Autonomic Neuropathy
Keywords
Cardiac Autonomic Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
α-lipoic acid
Arm Type
Active Comparator
Arm Description
α-lipoic acid PO medication, 600mg per day, for 6weeks α-lipoic acid PO medication, 1200mg per day, for 6weeks
Arm Title
No treatment group
Arm Type
No Intervention
Arm Description
No Intervention
Intervention Type
Drug
Intervention Name(s)
α-lipoic acid
Other Intervention Name(s)
Neuropaid OD Tablet
Intervention Description
α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks
Primary Outcome Measure Information:
Title
Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
Description
check the Heart rate variability(HRV) Index
Time Frame
up to 24weeks
Secondary Outcome Measure Information:
Title
Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
Description
Check the Autonomic Nerve System(ANS) function 5 test
Time Frame
up to 24weeks
Other Pre-specified Outcome Measures:
Title
Number of Patients with Adverse events as a Measure of Safety
Description
Check the Number of Adverse events
Time Frame
up to 24weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bong Yun Cha, MD, PhD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Eulji General Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Sejong General Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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