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

NCT ID: NCT02056366

Last Updated: 2014-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-09-30

Brief 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.

Detailed 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)

Conditions

Type 2 Diabetes; Cardiac Autonomic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

α-lipoic acid

α-lipoic acid PO medication, 600mg per day, for 6weeks α-lipoic acid PO medication, 1200mg per day, for 6weeks

Group Type: ACTIVE_COMPARATOR

α-lipoic acid

Intervention Type: DRUG

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

No treatment group

No Intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

α-lipoic acid

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

Intervention Type: DRUG

Other Intervention Names

Neuropaid OD Tablet

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Chong Hwa Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bong Yun Cha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

The Catholic University of Korea

Seoul, Seoul, South Korea

Eulji General Hospital

Seoul, Seoul, South Korea

Sejong General Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

ALA_IIT01

Identifier Type: -

Identifier Source: org_study_id