Non-proliferative Diabetic Retinopathy, Diabetes Mellitus Type 2
Conditions
Keywords
Oxidative stress, Mitochondrial dysfunction, Ubiquinone, Antioxidant combined therapy, Diabetic retinopathy
Brief summary
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.
Detailed description
The investigators are interested in demonstrating the efficacy of Ubiquinone and combined antioxidant therapy in the pharmacological management of diabetic retinopathy since early stages.
Interventions
DRUGUbiquinone
400mg daily of oral ubiquinone for 24 weeks
(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
DRUGPlacebo
100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks
Sponsors
Instituto Mexicano del Seguro Social
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with type 2 diabetes mellitus * Patients with non proliferative diabetic retinopathy * Glycated hemoglobin \< 12.0% * Signing of informed consent
Exclusion criteria
* Patients with clinically significant macular edema * Patients with diabetic retinopathy advanced lesions that have required or require specific treatment (laser, vitrectomy) * Pretreatment with argon laser or excimer laser Ophthalmology surgery * Any other associated ocular pathology (glaucoma, cataracts, changing cornea dystrophy, macular degeneration) * Pregnancy, lactation, inadequate use of contraception * Antioxidant drug and/or supplements six months previous to enrollment * Renal and/or hepatic failure * Age under 30 or over 75 years * Severe cardiovascular disease (myocardial infarction, stroke, severe peripheral vasculopathy) * Blood dyscrasias * Have or have had cancer or other serious illness * Neurodegenerative process * Allergy to vitamins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative Stress markers | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mitochondrial dysfunction markers | 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 | 24 weeks | Evaluated with International clinical diabetic retinopathy disease severity scale, fluorescein angiography and color fundus photographs. Baseline and final stage. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Security profile | 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). |
Countries
Mexico
Outcome results
None listed