- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02056366
The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy (CANON)
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 Overview
Status
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Bong Yun Cha, MD, PhD, The Catholic University of Korea
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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