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

The Catholic University of Korea

Status and phase

Completed

Phase 4

Conditions

Cardiac Autonomic Neuropathy

Type 2 Diabetes

Treatments

Drug: α-lipoic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT02056366

ALA_IIT01

Details and patient eligibility

About

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.

Full 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)

Enrollment

91 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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