Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-04-12 @ 12:55 AM
Study NCT ID:
NCT02056366
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2014-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008063', 'term': 'Thioctic Acid'}], 'ancestors': [{'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-04', 'studyFirstSubmitDate': '2014-02-03', 'studyFirstSubmitQcDate': '2014-02-04', 'lastUpdatePostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Patients with Adverse events as a Measure of Safety', 'timeFrame': 'up to 24weeks', 'description': 'Check the Number of Adverse events'}], 'primaryOutcomes': [{'measure': 'Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy', 'timeFrame': 'up to 24weeks', 'description': 'check the Heart rate variability(HRV) Index'}], 'secondaryOutcomes': [{'measure': 'Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy', 'timeFrame': 'up to 24weeks', 'description': 'Check the Autonomic Nerve System(ANS) function 5 test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac Autonomic Neuropathy'], 'conditions': ['Type 2 Diabetes', 'Cardiac Autonomic Neuropathy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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\n\nSecondary Outcome Measures : Autonomic Nerve System(ANS) function 5 test, EuroQoL 5-Dimension Questionnaire(EQ-5D)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria :\n\n* Established Cardiac Autonomic Neuropathy in type 2 diabetes.\n* aged 20 years to 80 years\n* Capable of giving informed consent\n\nExclusion Criteria :\n\n* 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\n* HbA1C \\> 11%\n* Not controlled hypertension (SBP≥160mmHg, DBP≥100mmHg)\n* Diagnosed ketoacidosis within 4 weeks\n* Unstable cardiac disease (unstable angina or myocardial infarction )\n* Pregnancy\n* Involvement in other clinical trial in last 4 weeks\n* Known or suspected sensitivity to trial products"}, 'identificationModule': {'nctId': 'NCT02056366', 'acronym': 'CANON', 'briefTitle': 'The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ALA_IIT01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'α-lipoic acid', 'description': 'α-lipoic acid PO medication, 600mg per day, for 6weeks α-lipoic acid PO medication, 1200mg per day, for 6weeks', 'interventionNames': ['Drug: α-lipoic acid']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment group', 'description': 'No Intervention'}], 'interventions': [{'name': 'α-lipoic acid', 'type': 'DRUG', 'otherNames': ['Neuropaid OD Tablet'], 'description': 'α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks', 'armGroupLabels': ['α-lipoic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'The Catholic University of Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Eulji General Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Sejong General Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Bong Yun Cha, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Catholic University of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chong Hwa Kim', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}