Efficacy of Ubiquinone and Combined Antioxidant Therapy in Non-proliferative Diabetic Retinopathy
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|ClinicalTrials.gov Identifier: NCT02062034|
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : February 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Non-proliferative Diabetic Retinopathy Diabetes Mellitus Type 2||Drug: Ubiquinone Drug: Combined antioxidant therapy Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||January 2014|
400mg daily of oral ubiquinone for 24 weeks
400mg daily of oral ubiquinone for 24 weeks
Other Name: coenzyme Q10
Experimental: Combined antioxidant therapy
(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
Drug: Combined antioxidant therapy
(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 Comparator: Placebo
Placebo. 100mg daily oral intake for 24 weeks
100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks
Other Name: Inactive drug
- Oxidative Stress markers [ Time Frame: 24 weeks ]
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.
- Lipid peroxidation (baseline and final values) given as malondialdehyde (MDA) and 4-hydroxyalkenals (4HDA) expressed in μmol/L
- Nitric oxide (NO) Levels of the NO catabolites nitrites/nitrates expressed in pmol/mL (baseline and final values)
- Erythrocyte glutathion peroxidase activity measured in U/min/mg protein (baseline and final values)
- Erythrocyte catalase activity expressed in U/mg protein (baseline and final values)
- Total antioxidant capacity measured in milliequivalent/mL (baseline and final values)
- Erythrocyte membrane fluidity, calculated using the fluorescence ratio of the excimer (Ie) to monomer (Im). The Ie/Im ratio.
- Mitochondrial dysfunction markers [ Time Frame: 24 weeks ]
In this study the mitochondrial dysfunction markers are composed of hydrolysis of adenosine triphosphate and membrane fluidity in submitochondrial particles of platelets.
- 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.
- 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)
- Progression and regression of non-proliferative diabetic retinopathy [ Time Frame: 24 weeks ]
Evaluated with International clinical diabetic retinopathy disease severity scale, fluorescein angiography and color fundus photographs.
Baseline and final stage.
- Security profile [ Time Frame: 24 weeks ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062034
|Cardiovascular Research Unit, University of Guadalajara|
|Guadalajara, Jalisco, Mexico, 44340|
|Study Director:||Alejandra G. Miranda-Díaz, PhD||University of Guadalajara|
|Study Chair:||José A. Castellanos-González, M.Sc.||University of Guadalajara|
|Study Chair:||Adolfo D. Rodriguez-Carrizalez, M.Sc.||University of Guadalajara|