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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02056366
Other study ID # ALA_IIT01
Secondary ID
Status Completed
Phase Phase 4
First received February 3, 2014
Last updated February 4, 2014
Start date January 2010
Est. completion date September 2013

Study information

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

Clinical Trial 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.


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)


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
a-lipoic acid
a-lipoic acid 600mg PO medication,Per day, For 6weeks a-lipoic acid 1200mg PO medication,Per day, For 6weeks

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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