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

Phase 4CompletedNCT02056366

The Catholic University of Korea91 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Cardiac Autonomic Neuropathy

Interventions

α-lipoic acidDRUG

α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

The Catholic University of Korea

Seoul, Seoul, South Korea

Eulji General Hospital

Seoul, Seoul, South Korea

Sejong General Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy

check the Heart rate variability(HRV) Index

Time frame: up to 24weeks

Secondary Outcomes

Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy

Check the Autonomic Nerve System(ANS) function 5 test

Time frame: up to 24weeks

Data from ClinicalTrials.gov

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