Efficacy of Ubiquinone and Combined Antioxidant Therapy in Non-proliferative Diabetic Retinopathy

Phase 2

Completed

• Conditions: Non-proliferative Diabetic Retinopathy; Diabetes Mellitus Type 2
• Interventions: Drug: Ubiquinone; Drug: Combined antioxidant therapy; Drug: Placebo

• Registration Number: NCT02062034
• Lead Sponsor: University of Guadalajara

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2013-07-17
• Primary Completion: 2013-11
• Study Completion: 2014-01
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-11
• Last Update Submitted: 2014-02-11
• Study First Posted: 2014-02-13
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Patients with type 2 diabetes mellitus
• Patients with non proliferative diabetic retinopathy
• Glycated hemoglobin < 12.0%
• Signing of informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ubiquinone	Ubiquinone	400mg daily of oral ubiquinone for 24 weeks
Combined antioxidant therapy	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
Placebo	Placebo	Placebo. 100mg daily oral intake for 24 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cardiovascular Research Unit, University of Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico