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| Name | Class |
|---|---|
| Instituto Mexicano del Seguro Social | OTHER_GOV |
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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.
The investigators are interested in demonstrating the efficacy of Ubiquinone and combined antioxidant therapy in the pharmacological management of diabetic retinopathy since early stages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ubiquinone | Experimental | 400mg daily of oral ubiquinone for 24 weeks |
|
| Combined antioxidant therapy | Experimental | (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 |
|
| Placebo | Placebo Comparator | Placebo. 100mg daily oral intake for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ubiquinone | Drug | 400mg daily of oral ubiquinone for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative Stress markers | 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.
| 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mitochondrial dysfunction markers | In this study the mitochondrial dysfunction markers are composed of hydrolysis of adenosine triphosphate and membrane fluidity in submitochondrial particles of platelets.
|
| Measure | Description | Time Frame |
|---|---|---|
| Security profile | In this study the security profile markers are composed of intraocular pressure, visual acuity, renal function, and liver profile. Intraocular 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alejandra G. Miranda-DÃaz, PhD | University of Guadalajara | Study Director |
| José A. Castellanos-González, M.Sc. | University of Guadalajara | Study Chair |
| Adolfo D. Rodriguez-Carrizalez, M.Sc. | University of Guadalajara | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Research Unit, University of Guadalajara | Guadalajara | Jalisco | 44340 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22595020 | Result | 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. |
| Label | URL |
|---|---|
| The effect of rosuvastatin in Diabetic Polyneuropathy: A Phase 2a Randomized Double-blind Placebo-controlled Study | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 25, 2014 | |
| Reset | May 27, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 25, 2014 | May 27, 2014 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D028361 | Mitochondrial Diseases |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014451 | Ubiquinone |
| C024989 | coenzyme Q10 |
| D014975 | Lutein |
| D065146 | Zeaxanthins |
| C005948 | astaxanthine |
| D001205 | Ascorbic Acid |
| D014810 | Vitamin E |
| D015032 | Zinc |
| D003300 | Copper |
| ID | Term |
|---|---|
| D016227 | Benzoquinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D003067 | Coenzymes |
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| Combined antioxidant therapy | Drug | (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 |
|
|
| Placebo | Drug | 100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks |
|
|
| 24 weeks |
| Progression and regression of non-proliferative diabetic retinopathy | Evaluated with International clinical diabetic retinopathy disease severity scale, fluorescein angiography and color fundus photographs. Baseline and final stage. | 24 weeks |
| 24 weeks |
| D004700 | Endocrine System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D045762 |
| Enzymes and Coenzymes |
| D024341 | Xanthophylls |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |