Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT02062034
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2013-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Ubiquinone and Combined Antioxidant Therapy in Non-proliferative Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-05-27', 'releaseDate': '2014-04-25'}], 'estimatedResultsFirstSubmitDate': '2014-04-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D028361', 'term': 'Mitochondrial Diseases'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], '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'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014451', 'term': 'Ubiquinone'}, {'id': 'C024989', 'term': 'coenzyme Q10'}, {'id': 'D014975', 'term': 'Lutein'}, {'id': 'D065146', 'term': 'Zeaxanthins'}, {'id': 'C005948', 'term': 'astaxanthine'}, {'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D014810', 'term': 'Vitamin E'}, {'id': 'D015032', 'term': 'Zinc'}, {'id': 'D003300', 'term': 'Copper'}], 'ancestors': [{'id': 'D016227', 'term': 'Benzoquinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D024341', 'term': 'Xanthophylls'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-11', 'studyFirstSubmitDate': '2013-07-17', 'studyFirstSubmitQcDate': '2014-02-11', 'lastUpdatePostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Security profile', 'timeFrame': '24 weeks', 'description': 'In this study the security profile markers are composed of intraocular pressure, visual acuity, renal function, and liver profile.\n\nIntraocular pressure. expressed in mmHg (baseline and final values) Visual acuity measured in decimal scale (baseline and final values) Renal function: serum urea (mg/dL), serum creatinine (mg/dL). (Baseline and final values) Liver profile: total serum bilirubin (mg/dL), indirect bilirubin (mg/dL), direct bilirubin (mg/dL) (Baseline and final values).'}], 'primaryOutcomes': [{'measure': 'Oxidative Stress markers', 'timeFrame': '24 weeks', 'description': 'In this study the oxidative stress markers are composed of lipid peroxidation, nitric oxide, erythrocyte glutathion peroxidase activity, erythrocyte catalase activity, total antioxidant capacity and erythrocyte membrane fluidity.\n\n* Lipid peroxidation (baseline and final values) given as malondialdehyde (MDA) and 4-hydroxyalkenals (4HDA) expressed in μmol/L\n* Nitric oxide (NO) Levels of the NO catabolites nitrites/nitrates expressed in pmol/mL (baseline and final values)\n* Erythrocyte glutathion peroxidase activity measured in U/min/mg protein (baseline and final values)\n* Erythrocyte catalase activity expressed in U/mg protein (baseline and final values)\n* Total antioxidant capacity measured in milliequivalent/mL (baseline and final values)\n* Erythrocyte membrane fluidity, calculated using the fluorescence ratio of the excimer (Ie) to monomer (Im). The Ie/Im ratio.'}], 'secondaryOutcomes': [{'measure': 'Mitochondrial dysfunction markers', 'timeFrame': '24 weeks', 'description': 'In this study the mitochondrial dysfunction markers are composed of hydrolysis of adenosine triphosphate and membrane fluidity in submitochondrial particles of platelets.\n\n* Hydrolysis of adenosine triphosphate: The hydrolytic activity of mitochondrial F0/F1-ATPase (F0/F1-adenosine triphosphatase) was measured as the liberation of inorganic phosphate from platelet mitochondria. Expressed in nmol of phosphate. Baseline and final values.\n* Membrane fluidity in submitochondrial particles of platelets. Calculated usig the fluorescence ratio of the excimer (Ie) to monomer (Im). The Ie/Im ratio. (Baseline and final values)'}, {'measure': 'Progression and regression of non-proliferative diabetic retinopathy', 'timeFrame': '24 weeks', 'description': 'Evaluated with International clinical diabetic retinopathy disease severity scale, fluorescein angiography and color fundus photographs.\n\nBaseline and final stage.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oxidative stress', 'Mitochondrial dysfunction', 'Ubiquinone', 'Antioxidant combined therapy', 'Diabetic retinopathy'], 'conditions': ['Non-proliferative Diabetic Retinopathy', 'Diabetes Mellitus Type 2']}, 'referencesModule': {'references': [{'pmid': '22595020', 'type': 'RESULT', 'citation': 'Hernandez-Ojeda J, Cardona-Munoz EG, Roman-Pintos LM, Troyo-Sanroman R, Ortiz-Lazareno PC, Cardenas-Meza MA, Pascoe-Gonzalez S, Miranda-Diaz AG. The effect of ubiquinone in diabetic polyneuropathy: a randomized double-blind placebo-controlled study. J Diabetes Complications. 2012 Jul-Aug;26(4):352-8. doi: 10.1016/j.jdiacomp.2012.04.004. Epub 2012 May 16.'}], 'seeAlsoLinks': [{'url': 'http://clinicaltrials.gov/ct2/show/record/NCT01622777', 'label': 'The effect of rosuvastatin in Diabetic Polyneuropathy: A Phase 2a Randomized Double-blind Placebo-controlled Study'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of ubiquinone and combined antioxidant therapy on progression, clinical regression, oxidative stress markers and mitochondrial dysfunction in non-proliferative diabetic retinopathy.', 'detailedDescription': 'The investigators are interested in demonstrating the efficacy of Ubiquinone and combined antioxidant therapy in the pharmacological management of diabetic retinopathy since early stages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 2 diabetes mellitus\n* Patients with non proliferative diabetic retinopathy\n* Glycated hemoglobin \\< 12.0%\n* Signing of informed consent\n\nExclusion Criteria:\n\n* Patients with clinically significant macular edema\n* Patients with diabetic retinopathy advanced lesions that have required or require specific treatment (laser, vitrectomy)\n* Pretreatment with argon laser or excimer laser Ophthalmology surgery\n* Any other associated ocular pathology (glaucoma, cataracts, changing cornea dystrophy, macular degeneration)\n* Pregnancy, lactation, inadequate use of contraception\n* Antioxidant drug and/or supplements six months previous to enrollment\n* Renal and/or hepatic failure\n* Age under 30 or over 75 years\n* Severe cardiovascular disease (myocardial infarction, stroke, severe peripheral vasculopathy)\n* Blood dyscrasias\n* Have or have had cancer or other serious illness\n* Neurodegenerative process\n* Allergy to vitamins'}, 'identificationModule': {'nctId': 'NCT02062034', 'briefTitle': 'Efficacy of Ubiquinone and Combined Antioxidant Therapy in Non-proliferative Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of Guadalajara'}, 'officialTitle': 'Efficacy of Ubiquinone and Combined Antioxidant Therapy on Progression, Oxidative Stress Markers and Mitochondrial Dysfunction in Non-proliferative Diabetic Retinopathy: A Phase 2a Randomized Double-blind Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'RDNP-20100102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ubiquinone', 'description': '400mg daily of oral ubiquinone for 24 weeks', 'interventionNames': ['Drug: Ubiquinone']}, {'type': 'EXPERIMENTAL', 'label': 'Combined antioxidant therapy', 'description': '(1mg copper + 20mg zinc + 180mg vitamin C + 30mg vitamin E + 1mg zeaxanthin + 4mg astaxanthin + 10mg lutein) daily of oral antioxidant combined therapy for 24 weeks', 'interventionNames': ['Drug: Combined antioxidant therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo. 100mg daily oral intake for 24 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ubiquinone', 'type': 'DRUG', 'otherNames': ['coenzyme Q10'], 'description': '400mg daily of oral ubiquinone for 24 weeks', 'armGroupLabels': ['Ubiquinone']}, {'name': 'Combined antioxidant therapy', 'type': 'DRUG', 'otherNames': ['lutein', 'zeaxanthin', 'astaxanthin', 'vitamin C', 'vitamin E', 'zinc', 'copper'], 'description': '(1 mg copper, 20 mg zinc, 180 mg vitamin C, 30 mg vitamin E, 1 mg zeaxanthin, 4 mg astaxanthin, 10 mg lutein) daily of oral, all of them in one Tablet for 24 weeks', 'armGroupLabels': ['Combined antioxidant therapy']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Inactive drug'], 'description': '100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44340', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Cardiovascular Research Unit, University of Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'Alejandra G. Miranda-Díaz, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Guadalajara'}, {'name': 'José A. Castellanos-González, M.Sc.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Guadalajara'}, {'name': 'Adolfo D. Rodriguez-Carrizalez, M.Sc.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Guadalajara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guadalajara', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Alejandra Guillermina Miranda Diaz', 'investigatorAffiliation': 'University of Guadalajara'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-04-25', 'type': 'RELEASE'}, {'date': '2014-05-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Adolfo Daniel Rodriguez-Carrizalez, PhD, University of Guadalajara'}}}}