Type 2 Diabetes Clinical Trial
— CANONOfficial 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
Verified date | February 2014 |
Source | The Catholic University of Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 91 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Eulji General Hospital | Seoul | |
Korea, Republic of | Sejong General Hospital | Seoul | |
Korea, Republic of | The Catholic University of Korea | Seoul |
Lead Sponsor | Collaborator |
---|---|
The Catholic University of Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Patients with Adverse events as a Measure of Safety | Check the Number of Adverse events | up to 24weeks | Yes |
Primary | Primary Efficacy of a-lipoic Acid in patients with cardiac autonomic neuropathy | check the Heart rate variability(HRV) Index | up to 24weeks | No |
Secondary | Secondary Efficacy of a-lipoic Acid in patients with cardiac autonomic neuropathy | Check the Autonomic Nerve System(ANS) function 5 test | up to 24weeks | No |
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