Type 2 DiabetesPhase 4CANONNCT02056366
The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy
A Phase 4 study testing α-lipoic acid in people with Type 2 Diabetes and Cardiac Autonomic Neuropathy, run by The Catholic University of Korea at 3 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type 2 Diabetes, Cardiac Autonomic Neuropathy
- What is being tested?
- α-lipoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jan 2010to Sep 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established Cardiac Autonomic Neuropathy in type 2 diabetes.
- aged 20 years to 80 years
- Capable of giving informed consent
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
The Catholic University of Korea
Seoul, Seoul, 137-701
Eulji General Hospital
Seoul, Seoul
Sejong General Hospital
Seoul, Seoul
About this study
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
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.
Read the 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
- Being tested
- α-lipoic acid
- Keywords
- Cardiac Autonomic Neuropathy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
α-lipoic acidDrug
Also called Neuropaid OD Tablet
α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks
| Study group | Role | What they receive |
|---|---|---|
| α-lipoic acid | Active comparator | α-lipoic acid PO medication, 600mg per day, for 6weeks α-lipoic acid PO medication, 1200mg per day, for 6weeks Receives: Drug: α-lipoic acid |
| No treatment group | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
check the Heart rate variability(HRV) Index
Measured: up to 24weeks
Secondary outcomes (1)
Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
Check the Autonomic Nerve System(ANS) function 5 test
Measured: up to 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startJan 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Hwa Kim, The Catholic University of Korea
- Investigators
- Bong Yun Cha, MD, PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056366
- Sponsor's protocol ID
- ALA_IIT01
- Acronym
- CANON
- Status last verified
- Feb 2014
- First submitted
- 3 Feb 2014
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02056366
- Acronym / sponsor ID
- CANON / ALA_IIT01
- Conditions
- Type 2 Diabetes, Cardiac Autonomic Neuropathy
- Keywords
- Cardiac Autonomic Neuropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| α-lipoic acid | Active comparator | Drug: α-lipoic acidα-lipoic acid PO medication, 600mg per day, for 6weeks α-lipoic acid PO medication, 1200mg per day, for 6weeks |
| No treatment group | No intervention | –No Intervention |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established Cardiac Autonomic Neuropathy in type 2 diabetes.
- aged 20 years to 80 years
- Capable of giving informed consent
Key exclusion criteria (8 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| α-lipoic acidAlso: Neuropaid OD Tabletα-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks | Drug | α-lipoic acid |
Primary outcome
Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
Time frame: up to 24weeks
check the Heart rate variability(HRV) Index
1 secondary outcome
Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
Time frame: up to 24weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bong Yun Cha, MD, PhD principal investigator
The Catholic University of Korea
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing α-lipoic acid in people with Type 2 Diabetes and Cardiac Autonomic Neuropathy, run by The Catholic University of Korea at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy (time frame: up to 24weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2014.