The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy
CANON
1 other identifier
interventional
91
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes
Started Jan 2010
Longer than P75 for phase_4 type-2-diabetes
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 3, 2014
CompletedFirst Posted
Study publicly available on registry
February 6, 2014
CompletedFebruary 6, 2014
February 1, 2014
3.7 years
February 3, 2014
February 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
check the Heart rate variability(HRV) Index
up to 24weeks
Secondary Outcomes (1)
Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
up to 24weeks
Other Outcomes (1)
Number of Patients with Adverse events as a Measure of Safety
up to 24weeks
Study Arms (2)
α-lipoic acid
ACTIVE COMPARATORα-lipoic acid PO medication, 600mg per day, for 6weeks α-lipoic acid PO medication, 1200mg per day, for 6weeks
No treatment group
NO INTERVENTIONNo Intervention
Interventions
α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks
Eligibility Criteria
You may qualify if:
- Established Cardiac Autonomic Neuropathy in type 2 diabetes.
- aged 20 years to 80 years
- Capable of giving informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
The Catholic University of Korea
Seoul, Seoul, 137-701, South Korea
Eulji General Hospital
Seoul, Seoul, South Korea
Sejong General Hospital
Seoul, Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bong Yun Cha, MD, PhD
The Catholic University of Korea
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 3, 2014
First Posted
February 6, 2014
Study Start
January 1, 2010
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
February 6, 2014
Record last verified: 2014-02