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

Type 2 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056366
• Other study ID #: ALA_IIT01
• 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

Related Conditions & MeSH terms

• Cardiac Autonomic Neuropathy
• Nervous System Diseases
• Type 2 Diabetes

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