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NCT Number: NCT02056366

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

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.

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Key information

Conditions

Type 2 Diabetes Cardiac Autonomic Neuropathy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eulji General Hospital, Seoul, South Korea

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

α-lipoic acid

Drug

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

Other names: Neuropaid OD Tablet

Primary outcomes

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

    Time frame: up to 24weeks

    check the Heart rate variability(HRV) Index

Secondary outcomes

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

    Time frame: up to 24weeks

    Check the Autonomic Nerve System(ANS) function 5 test

Other outcomes

  1. Number of Patients with Adverse events as a Measure of Safety

    Time frame: up to 24weeks

    Check the Number of Adverse events

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study 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

Acronym: CANON

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 6, 2014
Registry last updated
Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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