A Phase 2 interventional study of Ubiquinone and Combined antioxidant therapy in Non-proliferative Diabetic Retinopathy and Diabetes Mellitus Type 2, sponsored by University of Guadalajara. Completed at 1 site in Mexico. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-13.
Sponsored by University of Guadalajara · Phase 2, Interventional, and Treatment
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.
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's enrollment of 61 is close to the median of 60 across 500 interventional studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →University of Guadalajara is the lead sponsor of 94 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
400mg daily of oral ubiquinone for 24 weeks
Drug: Ubiquinone
(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
Placebo. 100mg daily oral intake for 24 weeks
Drug: Placebo
400mg daily of oral ubiquinone for 24 weeks
Also known as: coenzyme Q10
(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
Also known as: lutein, zeaxanthin, astaxanthin, vitamin C, vitamin E, zinc, copper
100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks
Also known as: Inactive drug
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. * 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.
Time frame: 24 weeks
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. * 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)
Time frame: 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.
Time frame: 24 weeks
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).
Time frame: 24 weeks
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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University of Guadalajara