Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-24 @ 3:50 AM
Study NCT ID:
NCT01978405
Status:
UNKNOWN
Last Update Posted:
2013-11-08
First Post:
2013-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-Term Alpha Lipoic Acid Therapy for Prevention of Contrast-induced Acute Kidney Injury and Endothelial Dysfunction in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-06', 'studyFirstSubmitDate': '2013-10-25', 'studyFirstSubmitQcDate': '2013-10-31', 'lastUpdatePostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast induced acte kidney injury', 'timeFrame': '6 months'}, {'measure': 'The changes of endothelium-dependent arterial dilation before and after contrast administrated', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'Nephropathy', 'Contrast medium', 'Alpha lipoic acid'], 'conditions': ['Acute Kidney Injury', 'The Changes of Plasma Creatinine', 'The Changes of Plasma Free Radicals', 'The Changes of Endothelium-dependent Arterial Dilation']}, 'descriptionModule': {'briefSummary': 'Contrast-induced acute kidney injury (CIAKI) is a major complication with adverse outcomes after contrast media injection. Although the risk of developing CIAKI is low in patients with normal renal function, it is dramatically higher in patients with conditions such as diabetes mellitus (DM) or chronic kidney disease (CKD). More recently, our data showed that contrast agents can induce endothelial dysfunction partially via free radicals in diabetes. Therefore, strategies to prevent CIAKI and endothelial dysfunction in DM patients with CKD are urgently needed. Alpha-lipoic acid and its reduced form, dihydrolipoate, are potent antioxidants. We hypothesized that alpha lipoic acid can prevent the contrast-induced acute kidney injury and endothelial dysfunction in type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes\n* nephropathy (stage 3 and 4)\n\nExclusion Criteria:\n\n* recive alpha lipoic acid\n* type 1 diabetes\n* nephropathy (stagte 1, 2 and 5)\n* hypersensitivity to contrast media\n* IV heart failure\n* lactic acidosis'}, 'identificationModule': {'nctId': 'NCT01978405', 'briefTitle': 'Short-Term Alpha Lipoic Acid Therapy for Prevention of Contrast-induced Acute Kidney Injury and Endothelial Dysfunction in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan General Hospital of Guangzhou Military Command'}, 'officialTitle': 'Short-Term Alpha Lipoic Acid Therapy for Prevention of Contrast-induced Acute Kidney Injury and Endothelial Dysfunction in Type 2 Diabetes', 'orgStudyIdInfo': {'id': '2013Wze088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alpha-lipoic acid group', 'description': 'Alpha lipoic acid 600 mg in 0.9% sodium chloride 250 ml was given before and after contrast agent was administrated.', 'interventionNames': ['Drug: Alpha lipoic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo intervention group', 'description': 'Only 0.9% sodium chloride 250 ml was given for this group.', 'interventionNames': ['Drug: Alpha lipoic acid']}], 'interventions': [{'name': 'Alpha lipoic acid', 'type': 'DRUG', 'armGroupLabels': ['Placebo intervention group', 'alpha-lipoic acid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430070', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang Guangda, MD', 'role': 'CONTACT', 'phone': '+8602768878410'}], 'facility': 'Wuhan General Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Xiang Guangda, MD', 'role': 'CONTACT', 'email': 'Guangda64@hotmail.com', 'phone': '+8602768878410'}], 'overallOfficials': [{'name': 'Xiang Guangda, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wuhan General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiang Guang-da', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Endocrinol Dept.', 'investigatorFullName': 'Xiang Guang-da', 'investigatorAffiliation': 'Wuhan General Hospital of Guangzhou Military Command'}}}}